TPLC - Total Product Life Cycle

• Device: mask, surgical
• Regulation Description: Surgical apparel.
• Product Code: FXX
• Regulation Number: 878.4040
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3A MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
A PLUS INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALG HEALTH LLC
	SUBSTANTIALLY EQUIVALENT	1
ALLMED MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ALLMED MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ALLURE GIFT WRAPS PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ALTOR SAFETY LLC
	SUBSTANTIALLY EQUIVALENT	2
AMERICA'S SUPPLY CHAINS
	SUBSTANTIALLY EQUIVALENT	1
AMERICA’S SUPPLY CHAINS
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN SURGICAL MASK COMPANY LLC
	SUBSTANTIALLY EQUIVALENT	1
AMMEX-WEIDA (HUBEI) HEALTH AND SAFETY PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
AMPHASTAR NANJING PHARMACEUTICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANDON HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANHUI CLEANPRO PHARMPACK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANHUI JBH MEDICAL APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANQING MAYFIELD MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
AOK TOOLING LIMITED
	SUBSTANTIALLY EQUIVALENT	3
ARMBRUST INC.
	SUBSTANTIALLY EQUIVALENT	1
ASIA DYNAMICS INC., D/B/A ADI MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AZUR MEDICAL COMPANY INC.
	SUBSTANTIALLY EQUIVALENT	1
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BANYAN USA LLC
	SUBSTANTIALLY EQUIVALENT	1
BASE4 GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAYLAB USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
BDC DENTAL CORPORATION LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOBASE SCIENTIFIC (SHANDONG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BLACKBRIAR REGULATORY SERVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BYD PRECISION MANUFACTURER CO.LTD.
	SUBSTANTIALLY EQUIVALENT	1
BYD PRECISON MANUFACTURER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
C & S PAPER YUNFU CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU COMBAT PROTECTIVE EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
CHANGZHOU DSB MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU HOLYMED PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHAOZHOU CECILIA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHISON MEDICAL TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHONGQING CHAOKE INDUSTRY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHONGQING COE DISPLAY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHONGQING PA XIJIA BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHUZHOU DADDY'S CHOICE SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CLEARMASK, LLC
	SUBSTANTIALLY EQUIVALENT	1
CONOD MEDICAL CO., LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CONTROL PRINT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CROSS PROTECTION (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
CROWN NAME DISPOSABLE HYGIENE PRODUCTS FTY., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CUSTOMFAB, INC.
	SUBSTANTIALLY EQUIVALENT	1
DANAMECO MEDICAL JOINT STOCK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DEFENDER SAFETY INC.
	SUBSTANTIALLY EQUIVALENT	2
DEMETECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DIASIA BIOMEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONG GUAN KINYET METAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN MISSADOLA TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN RUNLIN MEDICAL SUPPLIES TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
	SUBSTANTIALLY EQUIVALENT	1
DUKAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DURIO PPE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
DWFRITZ AUTOMATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
ECOGUARD INC.
	SUBSTANTIALLY EQUIVALENT	1
EFOFEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENTREPRISE PREMONT INC.
	SUBSTANTIALLY EQUIVALENT	1
ESSTEE EXPORTS HEALTH CARE DIVISION
	SUBSTANTIALLY EQUIVALENT	1
EVERWIN TOYS (DONGGUAN)., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FELIKS PLASTIK LAMINASYON VE AMBALAJ MALZEMELERI SANAYI
	SUBSTANTIALLY EQUIVALENT	1
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
FOMED INDUSTRIES INC.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN NANHAI PLUS MEDICAL CO LTD
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN XINBAO TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FREUDENBERG PERFORMANCE MATERIALS LP
	SUBSTANTIALLY EQUIVALENT	1
FSSC, LLC
	SUBSTANTIALLY EQUIVALENT	1
FUJIAN KANG CHEN DAILY NECESSITIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
FUJIAN MEO MEDICAL TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GEMTIER MEDICAL (SHANGHAI) INC
	SUBSTANTIALLY EQUIVALENT	2
GOLDEN GRANDE CORP.
	SUBSTANTIALLY EQUIVALENT	1
GRI-ALLESET, INC
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG BIDA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG GOODFEELING HYGIENE MATERIAL TEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG JIA MEI BIOLOGICAL TECHNOLOGY CO.LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG KAIDI GARMENTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG KINGFA SCI. & TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG KINGFA SCI.&TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG KINGFA SCI.&TECH.CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG KINGFA SCI.&TECH.CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG LIDE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG WINSUN PERSONAL CARE PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG ZHIZHEN BIOLOGICAL MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG ZHONG LING INDUSTRIAL GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU MEI YI KANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU QUANTUM LASER INTELLIGENT EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU ZHENGKANG MEDICAL EQUIPMENT CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
GUILIN HBM SANITARY PROTECTIONS, INC
	SUBSTANTIALLY EQUIVALENT	1
HAIAN MEDIGAUZE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HAN ZHAOQING SPORTING GOODS COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU MYCODE BIO-MEDICINE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU QIANZHIYA SANITARY PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU RUNHENG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANTECH MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEARTLAND HEALTH PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HEILONGJIANG YINJIA MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HENAN CHAOYA MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HENAN HUIBO MEDICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HENAN YADU INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOMTEX, INC.
	SUBSTANTIALLY EQUIVALENT	2
HONEYWELL SAFETY PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
HUBEI HUANFU PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUBEI HUAQIANG HIGH-TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBEI KANGNING PROTECTIVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBEI KIMSOUL INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUBEI MEDIUNION MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBEI MEDLINK HEALTHCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HUBEI QIANJIANG KINGPHAR MEDICAL MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUBEI WANLI PROTECTIVE PRODUCTS CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
HUBEI WANLI PROTECTIVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBEI WOOZON HEALTHCARE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBEI XINXIN NON-WOVEN CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBEI YI-YA PROTECTIVE PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUIZHOU JIE BAI PURIFICATION CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUIZHOU TIANCHANG INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUNAN CHOPARD MEDICAL DEVICES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUNAN EEXI TECHNOLOGY & SERVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN EEXI TECHNOLOGY & SERVICE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN HENG CHANG PHARMACEUTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HUNAN TRIPLEX PRECISION MEDICAL DEVICES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUNAN YUANKANG BIOLOGICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
IMPERTECH INDUSTRIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMPROVE MEDICAL (HUNAN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNO LIFECARE
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORP.
	SUBSTANTIALLY EQUIVALENT	1
INTCO MEDICAL(HK) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IOB MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
IRIS USA
	SUBSTANTIALLY EQUIVALENT	1
J.K. PRIVATE STOCK INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANDE CHAOMEI DAILY CHEMICALS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGMEN NINGRUI MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGMEN SURE&ME MEDICAL PRODUCT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JIANYU HEALTH MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU MEDPLUS NON-WOVEN MANUFACTURER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU MEDPURE BIOLOGICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU NANFANG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU NEWVALUE MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU XINGTONG BIOTECHNOLOGY GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI 3L MEDICAL PRODUCTS GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI BESTGRAND HEALTH TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI FEILIKANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI GANLONG PHARMACEUTICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI HEYING PHARMACEUTICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANHAO MEDICAL INSTRUMENTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANXIN MEDTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIAXING AMAZING TRAVEL-WARE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JIN PIN ELECTRICAL CO., LTD. ZHUHAI S.E.Z.
	SUBSTANTIALLY EQUIVALENT	1
JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JINHUA JINGDI MEDICAL SUPPLIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIUJIANG TAIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
JSN HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
JUNTECH(JIAXING)HEALTHCARE MATERIALS CO,.LTD
	SUBSTANTIALLY EQUIVALENT	1
KDI MED SUPPLY
	SUBSTANTIALLY EQUIVALENT	1
KENPAX INTERNATIONAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
KINGSTAR MEDICAL (XIANNING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KNH SURGICAL FACE MASK
	SUBSTANTIALLY EQUIVALENT	1
LEAR CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
LIAONING SHENGJINGTANG BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIBERTY MASK LLC
	SUBSTANTIALLY EQUIVALENT	1
LITTLE RAPIDS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LONESTAR MEADOWS LLC
	SUBSTANTIALLY EQUIVALENT	1
LUCKY TEXTILE INDUSTRIAL(WUXI) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUOYANG SUNMED DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LYNCMED MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MACHENG THIMBLE TECHNOLOGY INVESTMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MAF CLOTHING PVT LTD UNIT-3
	SUBSTANTIALLY EQUIVALENT	1
MAGNUM HEALTH AND SAFETY PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
MAKRITE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MEDTECS (TAIWAN) CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEGASOFT (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEXPO INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
MID-AMERICA SAFETY CORP.
	SUBSTANTIALLY EQUIVALENT	1
MODERN HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
NANCHANG KANGHUA HEALTH MATERIALS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NANJING 3H MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANTONG TAIWEISHI MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
NATIONAL BRIDGE INDUSTRIAL (S.Z.) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NATON BIOTECHNOLOGY (BEIJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO GREEN TEXTILE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO JINGEAO ELECTRONICS INC.
	SUBSTANTIALLY EQUIVALENT	2
NINGBO OUHAN MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO SHUN YE MEDICAL COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NP MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
ORIGINAL MATTRESS FACTORY INC.
	SUBSTANTIALLY EQUIVALENT	1
OWENS & MINOR (O&M) HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	7
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PADM MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
PANEFFORT, LLC
	SUBSTANTIALLY EQUIVALENT	1
PFM MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
PHU BAO GROUP COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PLASTIKON INDUSTRIES
	SUBSTANTIALLY EQUIVALENT	1
PM EXCELLENCE LLC
	SUBSTANTIALLY EQUIVALENT	1
POINTCORE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREMIER GUARD USA LLC
	SUBSTANTIALLY EQUIVALENT	1
PREMIUMESTORE, LLC
	SUBSTANTIALLY EQUIVALENT	2
PRIMED MEDICAL PRODUCTS INC.
	SUBSTANTIALLY EQUIVALENT	1
PURAVITA M, LLC
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO LIKANGYUAN MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
QINGHAI ZHONG DAO WIN-WIN MEDICAL PROTECTIVE EQUIPMENT CO.,
	SUBSTANTIALLY EQUIVALENT	1
QINHUANGDAO TAIZHI MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
QIQIHAR HENGXIN MEDICAL SUPPLIES, LTD.
	SUBSTANTIALLY EQUIVALENT	2
R&G SEGURIDAD E HIGIENE INDUSTRIAL S.A.C.
	SUBSTANTIALLY EQUIVALENT	1
R&R MEDICAL CORPORATION LTD
	SUBSTANTIALLY EQUIVALENT	1
RAY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
REMADE USA LLC
	SUBSTANTIALLY EQUIVALENT	1
RFX+CARE MANUFACTORING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ROKI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SAFESOURCE DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SAFEWAY INDUSTRY HEALTHCARE.
	SUBSTANTIALLY EQUIVALENT	1
SAMPLE KING MANUFACTURING LTD
	SUBSTANTIALLY EQUIVALENT	1
SAN-M PACKAGE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SAVEWO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SECURED ORTHO MANUFACTURING OF AMERICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG AIDA MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG POP JEANS INTELLIGENT MANUFACTURING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG SHENGQUAN NEW MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG SHENGQUAN NEW MATERIALS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG T&F NONWOVEN CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG XINGYU GLOVES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI HUA EN INDUSTRIAL CO LTD
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI NO.9 KNITTING MILL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI YUNQING INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANTOU T&K MEDICAL EQUIPMENT FACTORY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN EVERWIN PRECISION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HYGENIX INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JINKO INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LYTTOP HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PENINSULA MEDICAL CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN REALTONE MEDICAL APPLIANCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SAFESECURE MEDICAL INFECTION CONTROL TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN PHARMACEUTICAL. INC.
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SKYPRO MEDICAL SUPPLIES COMPANY
	SUBSTANTIALLY EQUIVALENT	1
SOCIAL MEDICAL SUPPLY LLC
	SUBSTANTIALLY EQUIVALENT	1
SPARTA EAST, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINTECH LLC
	SUBSTANTIALLY EQUIVALENT	2
SQ MEDICAL SUPPLIES INC.
	SUBSTANTIALLY EQUIVALENT	1
STRING KING LACROSSE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SUNSMED PROTECTIVE PRODUCTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUPERMAX HEALTHCARE CANADA – SUPERMAX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SUPERMAX HEALTHCARE CANADA-SUPERMAX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU BOLISI MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU JANEE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU LETIAN PROTECTIVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIJI MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN SEAFOOD AND FISH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TAIZHOU DONGHAIXIANG PROTECTIVE EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TEXAS MEDPLAST LLC
	SUBSTANTIALLY EQUIVALENT	1
THE ALEEN INTERNATIONAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
THE GOOD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TIANCHANG KANGHUI PROTECTIVE PRODUCTS CO LTD
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN AOSHANG OUTDOOR EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN SAIYUAN TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN TEDA JINSHAN EASY PACKING MANUFACTURE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TOPWIDE (HUBEI) MEDICAL PRODUCTS MANUFACTURER
	SUBSTANTIALLY EQUIVALENT	1
TUOSHENG PROTECTIVE PRODUCTS (NINGBO) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
U-PLAY PRODUCTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
UNICOGLOBAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNIMAX MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNISOURCES GROUP LLC
	SUBSTANTIALLY EQUIVALENT	1
UNITED SEWING AUTOMATION INC.
	SUBSTANTIALLY EQUIVALENT	1
UNIVERSAL INCORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VR VERTICAL LLC DBA XRGO
	SUBSTANTIALLY EQUIVALENT	1
WANXINDA (GUANGZHOU) TECHNOLOGY PRODUCT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
WEALTH LEAD INDUSTRIAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI DISHANG MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLMED DENTAL MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLPOWER SPORTING GOODS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WELSPUN INDIA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
WEPON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILSON TECH (INTERNATIONAL) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
WINNER MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUHAN DYMEX HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN HUASHIDA PROTECTIVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN RAYTEX PROTECTION CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
WYZ MEDICAL SUPPLIES LLC
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN BLUE STAR ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN EAGLEDON PHARMACEUTICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN PROBTAIN MEDICAL TECHOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
XIANNING ECO MEDICAL ARTICLES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO DAOQI PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO DEMING HEALTHCARE PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO DINGCHENG NON-WOVEN PRODUCT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO JUNHUI PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO SANDA INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO ZHIBO NONWOVEN PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO ZHONGYI SAFETY & PROTECTION PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO ZHUOBO INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XINGYU MEDICAL TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XINXIANG KANGBEIER MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YOUNG DENTAL MANUFACTURING CO. 1, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG HONGYU MEDICALI COMMODITY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG LANHINE MEDICAL PRODUCTS LTD
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG SENHONG MEDICAL&INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG THE PURPLES PROTECTIVE PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHENDE MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHENDE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHONGSHAN SAIFUTE LABOR PROTECTIVE ARTICLES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI GAOGE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI HERALD DATANETICS LIMITED.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	59	59
2021	66	66
2022	21	21
2023	21	21
2024	21	21
2025	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	68	68
Patient-Device Incompatibility	37	37
Break	13	13
Product Quality Problem	11	11
Component Incompatible	11	11
Insufficient Information	7	7
Compatibility Problem	6	6
Patient Device Interaction Problem	6	6
Defective Device	5	5
Device Emits Odor	4	4
Nonstandard Device	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Appropriate Term/Code Not Available	3	3
Material Split, Cut or Torn	2	2
Device Markings/Labelling Problem	2	2
Material Integrity Problem	2	2
Contamination	2	2
Protective Measures Problem	2	2
Device-Device Incompatibility	1	1
Device Contaminated During Manufacture or Shipping	1	1
Physical Resistance/Sticking	1	1
Material Puncture/Hole	1	1
Short Fill	1	1
Defective Component	1	1
Expiration Date Error	1	1
Contamination /Decontamination Problem	1	1
Use of Device Problem	1	1
Component Missing	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Detachment of Device or Device Component	1	1
Device Reprocessing Problem	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	30	30
Rash	30	30
No Clinical Signs, Symptoms or Conditions	24	24
Dyspnea	18	18
Itching Sensation	15	15
Headache	14	14
Skin Inflammation/ Irritation	14	14
Insufficient Information	11	11
No Known Impact Or Consequence To Patient	11	11
Dizziness	11	11
Reaction	10	10
Local Reaction	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Anxiety	7	7
Asthma	7	7
Erythema	6	6
Skin Irritation	6	6
Cough	5	5
Burning Sensation	5	5
Discomfort	4	4
Vertigo	4	4
Blister	4	4
Cognitive Changes	4	4
Syncope/Fainting	4	4
Sore Throat	3	3
Fatigue	3	3
Pain	3	3
Inflammation	2	2
Abrasion	2	2
Dry Eye(s)	2	2
Aspiration/Inhalation	2	2
Chest Tightness/Pressure	2	2
Eye Pain	2	2
Bacterial Infection	2	2
Red Eye(s)	2	2
Caustic/Chemical Burns	2	2
Swelling/ Edema	2	2
Emotional Changes	2	2
Depression	2	2
Angioedema	1	1
Excessive Tear Production	1	1
Uveitis	1	1
Sensitivity of Teeth	1	1
Airway Obstruction	1	1
Irritability	1	1
Loss of consciousness	1	1
Loss of Vision	1	1
Corneal Clouding/Hazing	1	1
Fainting	1	1
Unspecified Respiratory Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	AMD Medicom Inc.	II	Feb-16-2024
2	O&M HALYARD, INC.	II	Dec-20-2024
3	Owens & Minor Distribution, Inc.	III	Feb-03-2023