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TPLC - Total Product Life Cycle

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Device polymer patient examination glove
Definition A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Product CodeLZA
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
5R MED INSTRUMENTS (CHENGDU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AAMEDIX GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
ALCATRON GLOVES FACTORY
  SUBSTANTIALLY EQUIVALENT 1
AMAZING RUBBER PRODUCTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN PERFORMANCE POLYMERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AMMEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ANHUI FINE GLOVE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI LNTCO MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI POWERGUARD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI XINYISHENG MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI ZHONG LIAN LATEX GLOVES MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 4
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
AT GLOVE ENGINEERING SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BESTSAFE GLOVE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BETTER CARE PLASTIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BLUE SAIL MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BLUE SAIL MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BRIGHTWAY HOLDINGS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
BRIGHTWAY HOLDINGS SDN BHD.
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTWAY HOLDINGS SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
BYD AUTO INDUSTRY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREGLOVE GLOBAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CAREGLOVE GLOBAL SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
CAREPLUS (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CENTRAL MEDICARE SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU XINGRONG MEDICAL TECHNOLOGY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU YIHUA SANITATION MATERIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHUZHOU HARMONY GLOVES MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
CLOVER GLOVE COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
COMFORT RUBBER GLOVES INDUSTRIES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K171541  Powder Free Nitrile Examination Gloves (Orange)
  2.  K190080  Powder Free Nitrile Examination Gloves Tested for ...
  3.  K192954  Power Free Nitrile Examination Gloves Tested for U ...
  4.  K200181  Black Colored Powder Free Nitrile Examination Glov ...
CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DEZHOU PURISM MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIPPED PRODUCTS (THAILAND) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DONG TAI CITY HUAYI GLOVES CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN GRINVALD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DR.BOO COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DURAMITT SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
ECO MEDI GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
ECO MEDI GLOVE SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
EDMA GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 2
ELM TREE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EONS GLOVES (THAILAND) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EVER GLOBAL (VIETNAM) ENTERPRISE CORP
  SUBSTANTIALLY EQUIVALENT 1
EVER GLOBAL (VIETNAM) ENTERPRISE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EVER GROWTH (VIETNAM) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
FITONE LATEX PRODUCTS CO., LTD. GUANGDONG
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJIAN CHUNHUI MEDICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJIAN ERCON MEDICAL MANAGEMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJIAN YUANXIN SAFETY PROTECTION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOVMASTER SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
GMP MEDICARE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
GMP MEDICARE SDN BHD (F25)
  SUBSTANTIALLY EQUIVALENT 1
GRAND WORK PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GREAT ECO GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
GREAT HARVEST TRADING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANG DONG KINGFA SCI. & TECH.CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG JIALI PHARMACEUTICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG KINGFA SCI. & TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG XINGCAN BROTHERS MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU JUNDA GLOVES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HAINING MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HARBOUR HEALTH LLC
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA NGC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 10
HARTALEGA SDB. BHD.
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
HARTALEGA SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 9
HE CHUANG PLASTIC & RUBBER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEALTHY GLOVE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI KANGXIDA MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HENGCHANG (DONGYING) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HENGCHANG (DONGYING) MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HI-CARE THAI GLOVES CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONG SENG GLOVES SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
HSK MEDICAL APPARATUS FOSHAN CHINA CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
HUAYUAN MEDICAL TECHNOLOGY(SHANGQIU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HYCARE INTERNATIONAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ICONIC MEDICARE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
INNER MONGOLIA BOMING MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNER MONGOLIA CUREGUARD MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
IVORY GLOVES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU BYTECH MEDICAL SUPPLIES CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CHERISH MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CUREGUARD GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
JIANGSU DIHONG INDUSTRY AND TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU DONGXIN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HEALTH-PEACE MEDICAL TECHNOLOGY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JINKE PROTECTIVE EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JINLIAN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU MAOLIN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SHENGLIJIE SAFETY PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU STANDARD HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU TIANSHUO MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU U-MED RUBBER & PLASTIC PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YANFANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI KEMEI MEDICAL APPARATUS & INSTRUMENTS GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI RONGLAI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI SANHAO MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI SUREFINE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIUJIANG TAIXIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
KOON SENG SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
KOON SENG SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
KOSSAN INTERNATIONAL SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 5
KSG MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
LANHUO MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
LEPING SHENGDE MEDICAL TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIENTEH TECHNOLOGY SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
LULIANG HONGRUIDA HEALTH PROTECTION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LYNCMED MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAH SING HEALTHCARE SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
MEDI LEGION SDN.BHD
  SUBSTANTIALLY EQUIVALENT 1
MEDITECH GLOVES SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEGINE INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
MERCATOR MEDICAL (THAILAND) LTD
  SUBSTANTIALLY EQUIVALENT 1
MERCATOR MEDICAL (THAILAND) LTD.
  SUBSTANTIALLY EQUIVALENT 4
MEXPO INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MULTISAFE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
NANJING UNIVERSAL MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NATHAN TRADING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NAUTILUS GLOVES LLC
  SUBSTANTIALLY EQUIVALENT 1
NB MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NIUJIAN TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NIUJIAN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOVID PPE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
NTL INNOVATION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
O & M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
O & M HAYLARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
O&M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONE GLOVE INDUSTRIAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
ONETEXX SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
OWENS & MINOR HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PASTEL GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PENTAVEST HOLDINGS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PHU DUC HUY PRODUCTION TRADING SERVICES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PINGAN MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLATINUM GLOVE INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PROFESSIONAL LATEX SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PROTECT GLOVES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PT. MAJA AGUNG LATEXINDO
  SUBSTANTIALLY EQUIVALENT 2
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PT. UNIVERSAL GLOVES
  SUBSTANTIALLY EQUIVALENT 1
REAL STAR MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHINO HEALTH INC
  SUBSTANTIALLY EQUIVALENT 1
RIMBA GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
RIMBA GLOVE SND BHD
  SUBSTANTIALLY EQUIVALENT 1
RIVERSTONE RESOURCES SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
RUBBEREX ALLIANCE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
SANREA HEALTHCARE PRODUCTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
SEMPERIT INVESTMENTS ASIA PTE LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEMPERIT INVESTMENTS ASIA PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG BLUE SAIL HEALTH TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG DS SAFETY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HENGYA PACKAGING PRINTING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUIWOSHENG HEALTH TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG JIESHI MEDICAL PRODUCTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG XINGYU GLOVES CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANXI HONGJIN PLASTIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANXI NACOSA MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHEN WEI USA INC.
  SUBSTANTIALLY EQUIVALENT 14
SHENZHEN SHIQIAO SCIENCE AND TECHNOLOGY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SHOWA BEST GLOVE, INC
  SUBSTANTIALLY EQUIVALENT 1
SHOWA BEST GLOVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIAM NTD CORPORATION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIYANG JAYSUN MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIYANG THREEGUARD MEDICAL SUPPLIES CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMART GLOVE CORPORATION SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
SMART GLOVE CORPORATION SDN.BHD
  SUBSTANTIALLY EQUIVALENT 1
SMART GLOVE CORPORATION SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
SRI TRANG GLOVES (THAILAND) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SRI TRANG GLOVES (THAILAND) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SRIRUNGRUANG GLOBAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STAR INVESTMENT AND TRADE JOINT STOCK COMPANY
  SUBSTANTIALLY EQUIVALENT 1
STRONGHOLD GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT GLOVE, INC
  SUBSTANTIALLY EQUIVALENT 2
SUQIAN LINGLIAN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SYNTEX HEALTHCARE PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAISHAN WEIBANG MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIZHOU KANGJIAN MEDICAL EQUIPMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN LANHAI MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI MEDICAL GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI RUBBER GLOVES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI RUBBER INDUSTRY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN AOSHANG OUTDOOR EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TK HITECH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOP GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
TOP GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
TOP QUALITY GLOVE SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
UG GLOBAL RESOURCES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
USA GLOVES
  SUBSTANTIALLY EQUIVALENT 1
UWEPORT LLC.
  SUBSTANTIALLY EQUIVALENT 1
VIETGLOVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIP GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
WATCHTOWER PPE SUPPLIES INC.
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WRP ASIA PACIFIC SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
WUHAN HUIRUI TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WUHAN ZONSEN MEDICAL PRODUCTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
XINGYU MEDICAL TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
YINGXIANG GLOVE PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YTY INDUSTRY (MANJUNG) SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
YUNNAN HUAZHIYUAN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHANGJIAGANG FENGYUAN PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHANGJIAGANG HUAYUAN PROTECTIVE EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHENJIANG HUAYANG LATEX PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHENJIANG SUHUI LATEX PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO YAHAO SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 3 3
2019 20 20
2020 4 4
2021 20 20
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 10 10
Material Puncture/Hole 9 9
Patient-Device Incompatibility 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Product Quality Problem 4 4
Break 4 4
Device Contaminated During Manufacture or Shipping 3 3
Defective Device 3 3
Device Markings/Labelling Problem 3 3
Contamination 2 2
Contamination /Decontamination Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Expiration Date Error 1 1
Material Separation 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Material Discolored 1 1
Material Fragmentation 1 1
Hole In Material 1 1
Leak/Splash 1 1
Melted 1 1
Delivered as Unsterile Product 1 1
Packaging Problem 1 1
Torn Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 13 13
No Clinical Signs, Symptoms or Conditions 9 9
Rash 6 6
Hypersensitivity/Allergic reaction 4 4
Skin Irritation 2 2
Injury 2 2
Reaction 2 2
Skin Tears 1 1
Chemical Exposure 1 1
Skin Discoloration 1 1
No Information 1 1
Skin Burning Sensation 1 1
Swelling 1 1
Burning Sensation 1 1
Anaphylactoid 1 1
Laceration(s) 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Vitreous Floaters 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II May-06-2019
2 HUBO INTERNATIONAL INC II Apr-09-2021
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