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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 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
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
BAODING GUANZHONG GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
GLORMED COLOMBIA S.A.
  SUBSTANTIALLY EQUIVALENT 1
GRAND
  SUBSTANTIALLY EQUIVALENT 10
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HONG DI PLASTIC PRODUCTS CO, LTD.
  SUBSTANTIALLY EQUIVALENT 4
JIANGSU ALFA GLOVE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU CUREGUARD GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
JIANGSU JAYSUN GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
LANGFANG HUILONG PLASTIC PRODUCT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 3
PINNACLE
  SUBSTANTIALLY EQUIVALENT 3
PRACTICAL PROTECTIVE PLASTIC MANUFACTORY LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM
  SUBSTANTIALLY EQUIVALENT 2
RICH MOUNTAIN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 7
SHANGHAI CHINASTAR CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI LANFAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEN WEI (USA), INC.
  SUBSTANTIALLY EQUIVALENT 5
SHIJIAZHANG HONGXIANG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L
  SUBSTANTIALLY EQUIVALENT 6
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SUPER SAFE PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SUQIAN
  SUBSTANTIALLY EQUIVALENT 3
TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TANGSHAN ZHONGYING PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEI FANG JIUZHOU GLOVES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 7
ZHANGJIAGANG HUAYUAN PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIBO
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Hole in material 1
Leak 1
No Known Device Problem 1
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 2 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cypress Medical Products LLC II Jan-11-2012
2 Gulf South Medical Supply Inc II Nov-15-2012
3 Kimberly-Clark Corporation II May-26-2009

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