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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
Regulation Description Non-powdered 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
AIDE PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIR PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENTENG PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CABIN PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DAHOON PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DAXWELL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DECENT PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FEIYUE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRIEND PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAND
  SUBSTANTIALLY EQUIVALENT 1
GRAND WORK PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEZE CITY GREEN FOOD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOPE PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INPRO TECHNOLOGY DEVICE FACTORY
  SUBSTANTIALLY EQUIVALENT 1
JEWEL PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIAWANG GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAIXUAN PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MADE PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAOYU MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANXI HONGJIN PLASTIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHIJIAZHUANG AOK PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG RICHFUL PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
SHUNTONG GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUPERMAX PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XINGYUAN PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGFA GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGHE PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHAOFENG GLOVE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO
  SUBSTANTIALLY EQUIVALENT 2
ZIBO CHANGDA PLASTIC PRODUCTS COMPANY, LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ZIBO DAIYANG PLASTIC COMPANY
  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 1
ZIBO SANYING TRADE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO ZHOUHENG PLASTIC PRODUCTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Contamination During Use 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 2

Recalls
Manufacturer Recall Class Date Posted
1 CYPRESS MEDICAL PRODUCTS II Dec-12-2016
2 Cypress Medical Products LLC II Aug-16-2018

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