Import Alert 89-18
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 89-18
Published Date: 12/20/2022
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Filtering Facepiece Respirators (FFR)
Reason for Alert:
NOTE: The revision of this Import Alert (IA) dated 12/20/2022 updates the guidance section. Changes to the import alert are bracketed by asterisks (***).
A Filtering Facepiece Respirator (FFR) is a device that is a disposable half-face-piece non-powered air-purifying respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. An example of a disposable FFR that is classified as a medical device is an N95 respirator intended for use in a health care setting by healthcare personnel (HCP) or other wearers. FFRs that are devices must be FDA-cleared, exempt from 510(k), or authorized under an emergency use authorization (EUA).
On January 31, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to COVID-19. FDA had issued three EUAs that authorized certain FFRs, including NIOSH-approved FFRs (https://www.fda.gov/media/135763/download), imported non-NIOSH-approved disposable FFRs, and non-NIOSH-approved disposable FFRs manufactured in China, for use in healthcare settings by HCP. The EUAs for non-NIOSH-approved disposable respirators has been revoked as of July 6, 2021.
A Filtering Facepiece Respirator (FFR) is a device that is a disposable half-face-piece non-powered air-purifying respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. An example of a disposable FFR that is classified as a medical device is an N95 respirator intended for use in a health care setting by healthcare personnel (HCP) or other wearers. FFRs that are devices must be FDA-cleared, exempt from 510(k), or authorized under an emergency use authorization (EUA).
On January 31, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to COVID-19. FDA had issued three EUAs that authorized certain FFRs, including NIOSH-approved FFRs (https://www.fda.gov/media/135763/download), imported non-NIOSH-approved disposable FFRs, and non-NIOSH-approved disposable FFRs manufactured in China, for use in healthcare settings by HCP. The EUAs for non-NIOSH-approved disposable respirators has been revoked as of July 6, 2021.
Guidance:
Import Divisions may detain, without physical examination, shipments of FFRs identified on the Red List of this Alert. FFRs on the Red List include those that (a) appear to not be FDA-cleared, exempt from 510(k), or authorized under an EUA; and/or (b)those where FDA collected a sample, and NIOSH and/or WEAC testing indicates they do not meet the purported filtration efficiency level (https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html).
***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:***
APPLICATION TO RECONDITION: A product that is labeled or intended for use as an FFR, but that is not FDA-cleared, NIOSH-approved, or authorized by FDA for emergency use as an FFR, or that doesn't meet its purported efficiency level, could instead be used as a face mask. A face mask is a device that covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. A face mask is a device that must be FDA-cleared, exempt from 510(k), or authorized under an EUA. FDA has issued an EUA that authorizes face masks for use by the general public and HCP as source control when certain criteria are met, including some labeling requirements (https://www.fda.gov/media/137121/download). To be reconditioned as a face mask, among other things, the article would need to be labeled accurately to describe the product as a face mask, and to not claim to be intended for use as a surgical mask or as an FFR.
If an FFR is detained, the importer may submit a reconditioning application to FDA under 21 CFR 1.95. The importer will need to submit the Form FDA-766 directly to the Import Division compliance officer handling the entry. Additional requirements for release may be requested depending on the situation.
***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):***
FDA will remove products on the Red List of this import alert when evidence shows they meet applicable requirements.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox at cdrhimport@fda.hhs.gov
***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:***
APPLICATION TO RECONDITION: A product that is labeled or intended for use as an FFR, but that is not FDA-cleared, NIOSH-approved, or authorized by FDA for emergency use as an FFR, or that doesn't meet its purported efficiency level, could instead be used as a face mask. A face mask is a device that covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. A face mask is a device that must be FDA-cleared, exempt from 510(k), or authorized under an EUA. FDA has issued an EUA that authorizes face masks for use by the general public and HCP as source control when certain criteria are met, including some labeling requirements (https://www.fda.gov/media/137121/download). To be reconditioned as a face mask, among other things, the article would need to be labeled accurately to describe the product as a face mask, and to not claim to be intended for use as a surgical mask or as an FFR.
If an FFR is detained, the importer may submit a reconditioning application to FDA under 21 CFR 1.95. The importer will need to submit the Form FDA-766 directly to the Import Division compliance officer handling the entry. Additional requirements for release may be requested depending on the situation.
***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):***
FDA will remove products on the Red List of this import alert when evidence shows they meet applicable requirements.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox at cdrhimport@fda.hhs.gov
Product Description:
N95, KN95, MASK, RESPIRATOR, FFR, PROTECT, FACEMASKS
Charge:
For devices marketed without premarket notification:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k) application does not appear to have been determined substantially
equivalent or otherwise filed. [Misbranding, Section 502(o)]
OASIS charge code - NO 510(K)
For devices that appear to be adulterated because their quality falls below that which they are represented to possess:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its
purity or quality falls below, that which it purports or is represented to possess. [Adulteration, Section 501(c)]
OASIS charge code - DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k) application does not appear to have been determined substantially
equivalent or otherwise filed. [Misbranding, Section 502(o)]
OASIS charge code - NO 510(K)
For devices that appear to be adulterated because their quality falls below that which they are represented to possess:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its
purity or quality falls below, that which it purports or is represented to possess. [Adulteration, Section 501(c)]
OASIS charge code - DV QUALITY
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
ANSHUN HEALTH AND MEDICAL TECHNOLOGY CO LTD
Date Published : 07/31/2020
E6 Bldg Ind Sci And Tech Park , Xixiu
, Anshun,
Guizhou CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
76 - - - -- Dental
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: Runbo KN95; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
Aab (China) Co.,Ltd
Date Published : 07/07/2020
Hong Nanjie
, Quanzhoushi,
Fujiansheng CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: AAB Plus KN95 Protective Breathing Mask; Model KN95; Minimum filtration efficiency is 80.70%.
CTT Co., Ltd
Date Published : 07/07/2020
Building 2 Of Industril Park No 197 Xinhua Blvd, Tongqiao Town,Zhongkai High-Tech Zone
, Huizhou,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: KN95 Respirator mask; Model KN95; minimum filtration efficiency is 24.50%. Labeling makes medical claims and bears CE logo.
Chuzhou Qiao Dong Industrial Co, Ltd
Date Published : 07/07/2020
No 259 Shanghai North Road
, Chuzhou,
Anhui CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Langie High Filtration Efficiency Particulate Protection Respirator; Model Langie KN95 FFP2; Minimum filtration efficiency is 93.12%.;
Langie KN95 Respirator; Model KN95; minimum filtration efficiency is 93.12%
DADDYBABY CO.,LTD
Date Published : 07/07/2020
No. 308 Suan Lingcun , Xincuozhen Fuqing
, Fuzhou,
Fujian CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Protective Facemask; Model KN95 FFP2; minimum filtration efficiency is 90.61%.
DONG GUAN KING YEAR PAPER PRODUC
Date Published : 07/16/2020
NO. 30 Longhua Rd, Went , District, Dongguan.
, Dongguan,
CHINA
73 - - - -- Anesthesiology
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
74 - - - -- Cardiovascular
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
76 - - - -- Dental
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
77 - - - -- Ear,Nose And Throat
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
78 - - - -- Gastroenterological & Urological
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
79 - - - -- General & Plastic Surgery
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
80 - - - -- General Hospital/Personal Use
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
84 - - - -- Neurological
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
86 - - - -- Ophthalmic
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
87 - - - -- Orthopedic
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
89 - - - -- Physical Medicine
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
90 - - - -- Radiological
Date Published: 07/16/2020
Notes: 4-PLY Solid Protective Mask; Model FFP2 (N95); minimum filtration efficiency is 83.40%; product labeling improperly bears FDA, CE, & NIOSH logo.
DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD.
Date Published : 07/07/2020
Jinhe Road , No 78 Changping Jinmeicun; Changping Town
, Dongguan,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: AxKare; Model KN95-A; minimum filtration efficiency is 48.50%. Labeling bears CE logo.
DONGGUAN LEIHUO MEDICAL DEVICE CO LTD
Date Published : 07/07/2020
Dongshan Yongshenglu No. Room 47 , 101 Qishi; Dongshan Yongsheglu No
, Dongguan,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Non-Woven KN95; Model KN95; minimum filtration efficiency is 30.30%.
DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD
Date Published : 07/07/2020
Bubugaogaofu Lou 7 Room 301 , No. 40 Longyan Road
, Dongguan,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Tomson Newt; Model KN95; minimum filtration efficiency is 39.5%
FOSHAN NANHAI WEIJIAN SAN BANG PROTECTIVE PRODUCTS TECHNOLOG
Date Published : 07/29/2020
Nanhai District , No. 5 Workshop,No.19 Yongxing North Street,Liansha Shadun Hu Village Development Zone; Danzao Town
, Foshan,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
74 - - - -- Cardiovascular
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
76 - - - -- Dental
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
77 - - - -- Ear,Nose And Throat
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
78 - - - -- Gastroenterological & Urological
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
79 - - - -- General & Plastic Surgery
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
80 - - - -- General Hospital/Personal Use
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
84 - - - -- Neurological
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
86 - - - -- Ophthalmic
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
87 - - - -- Orthopedic
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
89 - - - -- Physical Medicine
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
90 - - - -- Radiological
Date Published: 07/29/2020
Notes: Self Priming Filter Type Particle Respirator; Model KN95 9051A minimum filtration efficiency is 94.21%
GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD
Date Published : 07/29/2020
A1 Workshop, No.10, Dongnan Xincun Avenue , Zone 2, Caobian No.3 Industrial Zone, Dali; Town Nanhai District
, Foshan City,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
74 - - - -- Cardiovascular
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
76 - - - -- Dental
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
77 - - - -- Ear,Nose And Throat
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
78 - - - -- Gastroenterological & Urological
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
79 - - - -- General & Plastic Surgery
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
80 - - - -- General Hospital/Personal Use
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
84 - - - -- Neurological
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
86 - - - -- Ophthalmic
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
87 - - - -- Orthopedic
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
89 - - - -- Physical Medicine
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
90 - - - -- Radiological
Date Published: 07/29/2020
Notes: KN95 Masks 5PLY; Model KN95 minimum filtration efficiency is 89.96%; Product labeling makes medical claims.;
Purvigor KN95 Mask; Model KN95; minimum filtration efficiency is 89.96%; product labeling makes medical claims.
GUANGDONG KAPER PROTECTION TECHNOLOGY CO., LTD
Date Published : 07/13/2020
No. 115 Xinghua Street , Dongfeng Town
, Zhongshan,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
74 - - - -- Cardiovascular
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
76 - - - -- Dental
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
79 - - - -- General & Plastic Surgery
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
84 - - - -- Neurological
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
86 - - - -- Ophthalmic
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
87 - - - -- Orthopedic
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
89 - - - -- Physical Medicine
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
90 - - - -- Radiological
Date Published: 07/13/2020
Notes: Protective Mask FFP2 Earloop;
Model KP-K02 (N95); minimum filtration efficiency is 86.90%
GUANGDONG NAFEI INDUST HOLDING
Date Published : 07/07/2020
4th Rd Ecological Tech
, Guangdong,
CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Care, Protective Masks; Minimum filtration efficiency is 6.80%. Labeling makes medical claims and bears CE logo
GUANGDONG QIAN JING TESTING CO., LTD.
Date Published : 07/07/2020
Floor 2, building B and floor 3, building D, No. 30, Development Zone, Liusha, Puning City
, Jieyang,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: DNW; Model KN95; minimum filtration efficiency is 85.5%, labeling makes medical claims and bears FDA, & CE logos.
GUANGZHOU AIYINMEI CO LTD
Date Published : 07/31/2020
Tieshanhe Road , F/2; No. 18-21 San Dong Avenue; Xinhuazhen Huadou
, Guangzhou,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
76 - - - -- Dental
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: A&F KN95; Model KN95; minimum filtration efficiency is 93.77%
GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD.
Date Published : 07/07/2020
Xixian Industrial Zone,Kengtou, Nancun Town , Panyu District
, Gaunzhou, Gaungdong,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: SUNJOY K1; Model KN95; minimum filtration efficiency is 22.00%. Labeling makes medical claims and bears FDA, & CE logos.
GUIZHOU BOCAI MEDICAL DEVICES CO LTD
Date Published : 07/31/2020
Medical And Health Industrial Park , Honghuagang
, Zunyi,
Guizhou CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
76 - - - -- Dental
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: KN95; Model KN95; minimum filtration efficiency is 90.22%. Product labeling appears to make medical claims.
Guangdong For You Essentials Manufacturing Co., Ltd
Date Published : 07/07/2020
No. 6 Shanhua Road,Yanghe Towm , Gaoming District
, Foshan,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: V Shine; Model KN95; minimum filtration efficiency is 94.51%.
HONGRITA PRECISION COMPONENT ZHO
Date Published : 06/22/2021
No. 26 Zhongzhun Road, C
, Zhongshan,
CHINA
80 L - - YU Accessory, Surgical Apparel
Date Published: 06/22/2021
Desc: "Leaf" Face Masks
80 M - - SH Respirator, surgical
Date Published: 06/22/2021
Desc: "Leaf" Face Masks
80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance
Date Published: 06/22/2021
Desc: "Leaf" Face Masks
Huizhou Jiahe Cube Technology Co., Ltd
Date Published : 07/29/2020
Shiziling (Plant), Chenjiang Street Office , Zhongkai Avenue; Chenjiangzhen Huicheng
, Huizhou,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
74 - - - -- Cardiovascular
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
76 - - - -- Dental
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
77 - - - -- Ear,Nose And Throat
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
78 - - - -- Gastroenterological & Urological
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
79 - - - -- General & Plastic Surgery
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
80 - - - -- General Hospital/Personal Use
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
84 - - - -- Neurological
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
86 - - - -- Ophthalmic
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
87 - - - -- Orthopedic
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
89 - - - -- Physical Medicine
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
90 - - - -- Radiological
Date Published: 07/29/2020
Notes: Jiahewell 5PLY; Model KN95 minimum filtration efficiency is 42.50%
IMPROVE MEDICAL (HUNAN) CO., LTD.
Date Published : 07/31/2020
No. 6 Yizhang East Avenue, Economic Development , District, 424200 Yizhang
, Chenzhou,
Hunan CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
76 - - - -- Dental
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: PPDS Ear Hook; Model KN95 Disposable Protective Respirator; minimum filtration efficiency is 94.63%
JIANGSU WEICHUANGLI NEW MATERIALS CO., LTD.
Date Published : 07/31/2020
Jute Technology Center , Shanghu; Town, Changshu
, Suzhou,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
76 - - - -- Dental
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: PULSAR KN95; Model PMN9520 KN95; minimum filtration efficiency is 89.40%
JIANGXI HORNET INDUSTRIAL COMPANY LIMITED
Date Published : 07/07/2020
Shuidong Industrial Park Ningdu County
, Ganzhou,
Jiangxi CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: 3D Nano Facial Protective Mask; Model S-KN95; Minimum filtration efficiency is 93.09%.
MEDICAL DEVICE BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL CO.,LT
Date Published : 07/30/2020
Of Building 4th Floor # 7 , No. 228 Jiaosong Road; Taiwanese Investment Zone
, Zhangzhou,
Fujian CHINA
73 - - - -- Anesthesiology
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
74 - - - -- Cardiovascular
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
76 - - - -- Dental
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
77 - - - -- Ear,Nose And Throat
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
78 - - - -- Gastroenterological & Urological
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
79 - - - -- General & Plastic Surgery
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
80 - - - -- General Hospital/Personal Use
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
84 - - - -- Neurological
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
86 - - - -- Ophthalmic
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
87 - - - -- Orthopedic
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
89 - - - -- Physical Medicine
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
90 - - - -- Radiological
Date Published: 07/30/2020
Notes: KN95 Protective Respirator; Model KN95; minimum filtration efficiency is 86.60%. Product labeling appears to make medical claims.
MINGJIANG MEDICAL SUPPLIES CO LTD
Date Published : 07/07/2020
Building 63 201 , Longgang District; Pinghu Town Fumin Industrial Area
, Shenzhen,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Multiple Layer Protective Mask; Model KN95; minimum filtration efficiency is 90.65%
NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD
Date Published : 07/07/2020
No. 26 Shangqiao Road, Xiwu Science Park, Fenghua
, Ningbo,
Zhejiang CHINA
73 K - - HA Mask, Scavenging
Date Published: 07/07/2020
Desc: Disposable Facemask
Notes: Elastic ear loop; minimum filtration efficiency is 8.70%; Labeling makes medical claims
80 F - - XX Mask, Surgical
Date Published: 07/07/2020
Desc: Disposable Facemask
Notes: Elastic ear loop; minimum filtration efficiency is 8.70%; Labeling makes medical claims
80 L - - YU Accessory, Surgical Apparel
Date Published: 07/07/2020
Desc: Disposable Facemask
Notes: Elastic ear loop; minimum filtration efficiency is 8.70%; Labeling makes medical claims
80 M - - SH Respirator, surgical
Date Published: 07/07/2020
Desc: Disposable Facemask
Notes: Elastic ear loop; minimum filtration efficiency is 8.70%; Labeling makes medical claims
80 N - - ZJ Respirator, n95, home use
Date Published: 07/07/2020
Desc: Disposable Facemask
Notes: Elastic ear loop; minimum filtration efficiency is 8.70%; Labeling makes medical claims
80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance
Date Published: 07/07/2020
Desc: Disposable Facemask
Notes: Elastic ear loop; minimum filtration efficiency is 8.70%; Labeling makes medical claims
QINGDAO ORPHILA MEDICAL TECHNOLOGY Co Limited
Date Published : 08/04/2020
Futai Square Room , No. 18 Hongkong Middle Road
, Qingdao,
Shandong CHINA
73 - - - -- Anesthesiology
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
74 - - - -- Cardiovascular
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
76 - - - -- Dental
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
77 - - - -- Ear,Nose And Throat
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
78 - - - -- Gastroenterological & Urological
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
79 - - - -- General & Plastic Surgery
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
80 - - - -- General Hospital/Personal Use
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
84 - - - -- Neurological
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
85 - - - -- Obstetrical & Gynecological
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
86 - - - -- Ophthalmic
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
87 - - - -- Orthopedic
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
89 - - - -- Physical Medicine
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
90 - - - -- Radiological
Date Published: 08/04/2020
Notes: RPHILA KN95 Respirator; Model KN95; minimum filtration efficiency is 94.76%. Product labeling appears to make medical claims.
SHANDONG DADDY'S CHOICE HEALTH SCIENCE AND TECHNOLOGY CO LTD
Date Published : 07/31/2020
Iandingfeng Road Garden Street Economic , Development Zone Linyi County
, Dezhou,
Shandong CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
76 - - - -- Dental
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: Purism KN95; Model KN95; minimum filtration efficiency is 94.23%
TIANJIN BENMO MEDICAL EQUIPMENT CO., LTD.
Date Published : 07/31/2020
D2-B1,Xuefu Industrial Zone West, No. 2 Xuefu Road,Xiqing District
, Tianjin,
Tianjin CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
76 - - - -- Dental
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: ONO Folding Respirator Protective Mask; Model KN95 AKF2002; minimum filtration efficiency is 91.10%
YIWU HENGHAO HOUSEHOLD PRODUCTS CO.,LTD
Date Published : 07/07/2020
Second Floor , No 18 Wenhua Road; Chianzhen Yiwu
, Jinhua,
Zhejiang CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Henghao KN95 Protective Masks; Model HH-KN95-001; Minimum filtration efficiency is 94.16%.
ZHEJIANG BAIYI INTELLIGENT GARMENT CO LTD
Date Published : 07/07/2020
Fengshan 1 Road Industrial Park , No. 1 Hangbu Town; Kecheng
, Quzhou,
Zhejiang CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: KN95 Respiratory Protection Mask; Model KN95; minimum filtration efficiency is 78.60%.
ZHEJIANG SHENGTAI BABY PRODUCTS Co Ltd
Date Published : 07/31/2020
No. 379 Dongkang Road
, Dongyang,
Zhejiang CHINA
73 - - - -- Anesthesiology
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
74 - - - -- Cardiovascular
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
76 - - - -- Dental
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
79 - - - -- General & Plastic Surgery
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
84 - - - -- Neurological
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
86 - - - -- Ophthalmic
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
87 - - - -- Orthopedic
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
89 - - - -- Physical Medicine
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
90 - - - -- Radiological
Date Published: 07/31/2020
Notes: KN95 Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%
ZHENGZHOU WANSHENSHAN HEALTHCARE PPE CO., LTD.
Date Published : 07/07/2020
Xinmi City , Group 8, Miaozhu Village, Quliang Town
, Zhengzhou,
Henan CHINA
73 - - - -- Anesthesiology
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
74 - - - -- Cardiovascular
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
76 - - - -- Dental
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
77 - - - -- Ear,Nose And Throat
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
78 - - - -- Gastroenterological & Urological
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
79 - - - -- General & Plastic Surgery
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
80 - - - -- General Hospital/Personal Use
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
84 - - - -- Neurological
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
85 - - - -- Obstetrical & Gynecological
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
86 - - - -- Ophthalmic
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
87 - - - -- Orthopedic
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
89 - - - -- Physical Medicine
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.
90 - - - -- Radiological
Date Published: 07/07/2020
Notes: Oriental Standard Particulate Respirator; Model KN95; minimum filtration efficiency is 89.10%.