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U.S. Department of Health and Human Services

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
ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANHUI INTCO MEDICAL PRODUCTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 2
ANHUI POWERGUARD TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BEST CARE TRADING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BETTER HEALTH MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BYTECH(DONGTAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIFENG HUAWEI MEDICAL SCIENCE&TECHNOLOGY 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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GRAND WORK PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG KINGFA SCI.& TECH.CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI ASTRO MEDICAL SUPPLY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNER MONGOLIA CUREGUARD MEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CUREGUARD GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU DIHONG INDUSTRY AND TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HUAYUAN MEDICAL TECHNOLOGY 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
LIAO NING SHANGWEI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIUPING TRADING CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUTAI MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG HONGXIN CHEMICALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG JIESHI MEDICAL PRODUCTS 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 ZHUSHI PHARMACEUTICAL GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SHENGDA MEDICAL APPLICATIONS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHEN WEI USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG HONGJUN PLASTIC MANUFACTURE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIAN HENGCHANG MEDICAL TECHNOLOGY 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
TOP GLOVE VIETNAM COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
XINYING TRADING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YUNNAN HUAZHIYUAN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2021 4 4
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 2 2
Patient-Device Incompatibility 2 2
Material Split, Cut or Torn 2 2
Contamination /Decontamination Problem 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Material Separation 1 1
Device Contamination with Body Fluid 1 1
Defective Device 1 1

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

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