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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 2
AMERICAN NITRILE OPERATIONS LLC
  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 FULEWEI ELECTRONIC 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 2
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
BETEL CARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
BETTER CARE PLASTIC TECHNOLOGY 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 2
BYD AUTO INDUSTRY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREGLOVE GLOBAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
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
CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DAINAM GLOVE JOINT STOCK COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DAXWELL, LLC
  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
ECO MEDI GLOVE SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
EDMA GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 2
EG GROUP PRODUCT AND SERVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ELM TREE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMERALD GLOVE MANUFACTURING SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
ENCOMPASS INDUSTRIES SDN. BHD.
  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 JIXIANG MEDICAL TECHNOLOGY 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
GOODGLOVES INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
GRAND WORK PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
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 3
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 2
GUANGDONG XINGCAN BROTHERS MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU JUNDA GLOVES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU KANGLING BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HAINING MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU RUNHENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARBOUR HEALTH LLC
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA NGC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 11
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 ASTRO MEDICAL SUPPLY 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 4
HSK MEDICAL APPARATUS FOSHAN CHINA CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
HUAYUAN MEDICAL TECHNOLOGY(SHANGQIU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HUMANWELL HEALTHCARE GROUP MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 3
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 5
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 JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO.,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 3
KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KGM GLOVES SDN. BHD.
  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
KOOVE IOT PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOSSAN INTERNATIONAL SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 5
KSG MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
LALAN RUBBERS (PVT) LTD
  SUBSTANTIALLY EQUIVALENT 1
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
LINGSHI HONGRUIDA HEALTH PROTECTION TECHNOLOGY CO., LTD.
  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
MASTERMAX PLASTIC (HUIZHOU) LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDI LEGION SDN.BHD
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GLOVE CO., LTD
  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
MEZORRISON MEDICAL TECHNOLOGY (DONGYING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOTEX HEALTHCARE (ANHUI) CO., LTD.
  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 5
O & M HAYLARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
O&M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
ONE GLOVE INDUSTRIAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
ONETEXX SDN BHD
  SUBSTANTIALLY EQUIVALENT 7
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. SHAMROCK MANUFACTURING CORPORA
  SUBSTANTIALLY EQUIVALENT 1
PT. SINTONG UNIGOLDEN GLOVE
  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 5
RUBBEREX ALLIANCE PRODUCTS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
RUBBEREX ALLIANCE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
SAFESKIN RETAILING (HK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SAFESOURCE DIRECT, LLC
  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 MAIDA MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 15
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 3
SRIRUNGRUANG GLOBAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST FUTURE INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STAR INVESTMENT AND TRADE JOINT STOCK COMPANY
  SUBSTANTIALLY EQUIVALENT 1
STRONGHOLD GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT GLOVE, INC
  SUBSTANTIALLY EQUIVALENT 3
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
TEC GLOVES INDUSTRY (M) SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
THAI MEDICAL GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI RAYONG PRODUCT GLOVE ZOUPURE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
THAI RUBBER GLOVES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI RUBBER INDUSTRY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
THANH CONG PHARMACEUTICAL AND TRADING 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 BLUE SAIL HEALTH TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO LANGU NEW MATERIAL TECHNOLOGY 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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 12 12
Material Puncture/Hole 11 11
Patient-Device Incompatibility 11 11
Adverse Event Without Identified Device or Use Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Product Quality Problem 5 5
Break 4 4
Defective Device 4 4
Material Integrity Problem 4 4
Device Markings/Labelling Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Physical Resistance/Sticking 2 2
Contamination 2 2
Contamination /Decontamination Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Expiration Date Error 1 1
Contamination of Device Ingredient or Reagent 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
Sharp Edges 1 1
Packaging Problem 1 1
Torn Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 14 14
Rash 7 7
Hypersensitivity/Allergic reaction 4 4
Exposure to Body Fluids 2 2
Erythema 2 2
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
Vitreous Floaters 1 1
Laceration(s) 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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