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	3
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
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	2
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
BAYLAB USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
BDC DENTAL CORPORATION , LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEATLES MEDICAL SUPPLIES (XIANTAO) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOBASE SCIENTIFIC (SHANDONG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BLACKBRIAR REGULATORY SERVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BYD PRECISON MANUFACTURER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDINALHEALTH
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU COMBAT PROTECTIVE EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
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
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	2
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 KINGFA SCI. & TECH.CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
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	2
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	2
HUNAN HENG CHANG PHARMACEUTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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 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 XINGTONG BIOTECHNOLOGY 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
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
KP TRADING CO., LTD.
	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	3
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MEDTECS (TAIWAN) CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEGASOFT (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MID-AMERICA SAFETY 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
O&M HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
ORIGINAL MATTRESS FACTORY, INC.
	SUBSTANTIALLY EQUIVALENT	1
OWENS & MINOR (O&M) HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	8
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PADM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PANEFFORT, LLC
	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	2
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	1
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 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 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 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
UNITED SEWING AUTOMATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNIVERSAL INCORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VITACORE INDUSTRIES, INC.
	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	3
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	1
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 HANGKANG MEDICAL EQUIPMENT CO., LTD.
	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
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
2021	67	114
2022	21	21
2023	21	21
2024	21	21
2025	11	11
2026	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	59	90
Patient-Device Incompatibility	22	22
Insufficient Information	9	9
Component Incompatible	9	9
Break	7	7
Patient Device Interaction Problem	7	7
Compatibility Problem	6	6
Product Quality Problem	5	5
Nonstandard Device	4	11
Defective Device	3	3
Contamination	3	3
Device Emits Odor	3	3
Appropriate Term/Code Not Available	3	5
Material Split, Cut or Torn	2	2
Material Puncture/Hole	2	2
Material Integrity Problem	2	2
Protective Measures Problem	2	2
Device-Device Incompatibility	1	1
Device Contaminated During Manufacture or Shipping	1	1
Defective Component	1	10
Manufacturing, Packaging or Shipping Problem	1	1
Use of Device Problem	1	1
Device Reprocessing Problem	1	1
Loss of or Failure to Bond	1	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Rash	28	28
Hypersensitivity/Allergic reaction	22	22
No Clinical Signs, Symptoms or Conditions	22	24
Skin Inflammation/ Irritation	17	17
Headache	14	15
Itching Sensation	14	15
Dyspnea	11	11
Local Reaction	11	11
Dizziness	10	10
Insufficient Information	9	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	9
Anxiety	7	38
Asthma	6	36
Syncope/Fainting	4	4
Erythema	4	4
Cough	4	4
Blister	4	4
Cognitive Changes	4	4
Vertigo	3	3
Pain	3	3
Eye Injury	3	3
Fatigue	3	3
Bacterial Infection	2	2
Sore Throat	2	2
Aspiration/Inhalation	2	2
Eye Pain	2	2
Emotional Changes	2	2
Abrasion	2	2
Caustic/Chemical Burns	2	2
Swelling/ Edema	2	2
Red Eye(s)	2	2
Burning Sensation	2	2
Depression	2	2
Discomfort	2	2
Loss of consciousness	1	1
Loss of Vision	1	1
Unspecified Respiratory Problem	1	1
Tachycardia	1	1
Irritability	1	1
Sensitivity of Teeth	1	1
Airway Obstruction	1	1
Excessive Tear Production	1	1
Muscle/Tendon Damage	1	1
Visual Impairment	1	1
Uveitis	1	1
Angioedema	1	1
Skin Burning Sensation	1	1
Unspecified Eye / Vision Problem	1	1
Alteration in Body Temperature	1	1
Vomiting	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