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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
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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