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TPLC - Total Product Life Cycle

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Device vinyl patient examination glove
Definition A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 CodeLYZ
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL DEVICES FACTORY
  SUBSTANTIALLY EQUIVALENT 1
AIDE PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIR PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALCATRON GLOVES FACTORY
  SUBSTANTIALLY EQUIVALENT 1
ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANHUI INTCO MEDICAL PRODUCTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 2
ANHUI KINDGUARD MEDICAL SUPPLIES TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
ANHUI POWERGUARD TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BENTENG PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEST CARE TRADING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BETTER HEALTH MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BETTER PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BETTERCARE PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K092294  VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLO ...
  2.  K092296  POWDER FREE EXAMINATION GLOVE
  3.  K092301  POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YEL ...
  4.  K092302  POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WIT ...
BYTECH DONGTAI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BYTECH(DONGTAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CABIN PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CANOPUS MEDICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARTAGLOVES S.A.
  SUBSTANTIALLY EQUIVALENT 1
CHANGDA PLASTIC PRODUCT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHIFENG HUAWEI MEDICAL SCIENCE&TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLEAN MEDICAL MANFACTURING CO;LTD
  SUBSTANTIALLY EQUIVALENT 1
CURON SCIENTIFIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DAHOON PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DAXWELL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DECENT PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEZHOU HENGCHANG MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DEZHOU HENGCHANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EVER GLOBAL (VIETNAM) ENTERPRISE CORP
  SUBSTANTIALLY EQUIVALENT 1
EVER GLOBAL (VIETNAM) ENTERPRISE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EVER GROWTH (VIETNAM) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
FEIYUE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRIEND PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FULL SYNERGY MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 6
GEENLI PLASTIC CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
GRAND WORK PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GRAND WORK PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GUANGDONG KINGFA SCI.& TECH.CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI ASTRO MEDICAL SUPPLY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI EXCELLENT PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEBEI FAVOR PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI GRANDEAST PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEBEI LEADER PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT
  SUBSTANTIALLY EQUIVALENT 2
HEBEI TENGDA PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEZE CITY GREEN FOOD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEZE JUXINYUAN FOOD CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HEZE YUZE GLOVE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HONG DI PLASTIC PRODUCTS CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
HONG DI PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONGXIN PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HONGZE PLASTIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HOPE PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUAILAI ZM PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HUANFU PLASTIC PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HUIFU TRADING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
IDEAL PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INMED GLOVES FACTORY
  SUBSTANTIALLY EQUIVALENT 1
INNER MONGOLIA CUREGUARD MEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INPRO TECHNOLOGY DEVICE FACTORY
  SUBSTANTIALLY EQUIVALENT 2
JEWEL PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU ALFA GLOVE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CUREGUARD GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU DIHONG INDUSTRY AND TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HANDSAFE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HUAYUAN GLOVES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JAYSUN GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU TOPTOUCH GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI JAYSUN MEDCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI SHENGDA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIAWANG GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIN ZHOU CHANG HAO PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAIXING PLASTIC PRODUCTS CO., LITD.
  SUBSTANTIALLY EQUIVALENT 1
KAIXUAN PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIAO NING SHANGWEI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFESTYLE SAFETY PRODUCTS (HUI ZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFESTYLE SAFTY PRODUCTS (HUI ZHOU) CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
LIUPING TRADING CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
LPL (HUI ZHOU) GLOVE
  SUBSTANTIALLY EQUIVALENT 1
LPL (HUI ZHOU) GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUTAI MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MADE PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
NACROUS PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NATURE MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOVAPRO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PING AN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 4
PREMIER MEDICAL GLOVES FACTORY
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS GLOVES PVT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
QUANTUM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
RAYEN SAFETY PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RAYU PLASTIC PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RICH MOUNTAIN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RONGYAO PLASTIC PRODUCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG AOBO MEDICAL CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG BLUE SAIL INNOVATION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAOYU MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HONGXIN CHEMICALS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HONGXIN CHEMICALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUAYUE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG JIANHONG NEW MATERIAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG JIESHI MEDICAL PRODUCTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG JUNFENG INDUSTRIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG LANGTAI INTERNATIONAL TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG SHENGSHIXINCHENG MEDICAL SCIENCE & TECHNOLOGY CO.,
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS &
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG TAIXIANG MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ZHANPENG MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ZHI HONG MEDICAL PRODUCTS, CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ZHIWEI MEDICAL PRODUCTS, CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ZHIYUAN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SHENGDA MEDICAL APPLICATIONS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANXI HONGJIN PLASTIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHEN WEI USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENYI(SHANDONG) PLASTIC PRODUCTS, CO.LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIJAZHUANG JIUYUAN PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG AOK PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG BENESTAR PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG CENTURY PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG ELEGANCE PLASTIC PRODUCT
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG FUHAO PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG GLORY PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG HONGJUN PLASTIC MANUFACTURE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG HYLAND PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG RICHFUL PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG SAIL PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG STAR PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG WALLY PLASTICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG WINFUL PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUNAG JIUYUAN PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHU TONG XINGHUA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHUN DA (XINGHUA) CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHUN TONG CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHUNTONG GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUPERMAX PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUPERMAX PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SUQIAN CLEAN GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAIAN HENGCHANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN CHANGRONG GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
TANGSHAN EXCELLENCE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN FUQIANG GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN GREEN HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
TANGSHAN HENGTONG PLASTIC PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HONGXING PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HONGYUN HEALTHCARE PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HONGYUN HEALTHCARE PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TANGSHAN HUAMEI HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN JIAXING PLASTIC PRODUCTS CO., LT
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
TANGSHAN KANGJIE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN KANGYUAN GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
TANGSHAN PUFA PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN QIXIN GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN YONGKANG GLOVE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN YONKSHUN GLOVE, CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
TANGSHAN ZHONGYING PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOP GLOVE VIETNAM COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TRUE GLOVE FACTORY
  SUBSTANTIALLY EQUIVALENT 2
WANG TONG XINGHUA CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
WANGDA PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WEALTH ON (JIANGSU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
WEIFANG BEIHAI COLOR PRINTING PACKAGGING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WEILIN PLASTIC AND RUBBER PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI BINGFA GAINLITE GLOVES CP., LTD
  SUBSTANTIALLY EQUIVALENT 1
XINFU MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XINGYUAN PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XINYING TRADING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XUANHUA METALLURGICAL INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGFA GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGHE PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGSHENG MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YOUNGSHENGPLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YUANHANG PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNNAN HUAZHIYUAN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
YURUN GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHANG JIA GANG HUAYUAN PLASTIC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHANGJIANGANG ALL FINE RUBBER-PLASTIC PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
ZHAOFENG GLOVE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHAOYANG PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHICHENG TRADING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZI BO YUXIANG GLOVES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBIO YINGJIE MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO BOLIN GLOVES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO BOXIANG PLASTIC & RUBBER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO CHANGDA PLASTIC PRODUCTS COMPANY, LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ZIBO DAIYANG PLASTIC COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ZIBO FLOURISH TRADING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ZIBO HONGCHIN PLASTIC AND RUBBER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO HUAQI TRADING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO INTCO MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZIBO LING YUN MEDICAL PRODUCTS CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO LITONG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZIBO SANYING TRADE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO TENGYUE PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO WANCI PLASTIC & RUBBER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO YINGBO MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
ZIBO YUE FAN MEDICAL PRODUCTS CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO YUECHUAN PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO YUQUN NEW MATERIAL SCIENCE AND TECHNOLOGY CO
  SUBSTANTIALLY EQUIVALENT 1
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZIBO ZHOUHENG PLASTIC PRODUCTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 1 1
2016 11 11
2017 6 6
2019 3 3
2020 1 1
2021 4 4
2022 1 1
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Split 7 7
Device Operates Differently Than Expected 5 5
Torn Material 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 3 3
Reaction 3 3
Material Puncture/Hole 2 2
Device Contamination with Body Fluid 2 2
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 2 2
Material Split, Cut or Torn 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 1 1
Contamination /Decontamination Problem 1 1
Defective Device 1 1
Material Separation 1 1
Contamination 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
Reaction 4 4
Exposure to Body Fluids 2 2
Hypersensitivity/Allergic reaction 2 2
Rash 2 2
Chemical Exposure 2 2
No Patient Involvement 2 2
Insufficient Information 2 2
Anaphylactoid 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Skin Irritation 1 1
No Consequences Or Impact To Patient 1 1
Death 1 1
Fungal Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CYPRESS MEDICAL PRODUCTS II Dec-12-2016
2 Cypress Medical Products LLC II Aug-16-2018
3 Cypress Medical Products LLC II Jan-11-2012
4 Gulf South Medical Supply Inc II Nov-15-2012
5 Kimberly-Clark Corporation II May-26-2009
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