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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device patient examination glove, specialty
Regulation Description Patient examination glove.
Definition A disposable latex examination glove is a device made of natural rubber latex or synthetic rubber that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminan. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
Product CodeLZC
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
KOSSAN LATEX
  SUBSTANTIALLY EQUIVALENT 1
METACURE SURGICAL GLOVES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
NITRITEX (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SGMP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEN WEI (USA), INC.
  SUBSTANTIALLY EQUIVALENT 2
WEAR SAFE
  SUBSTANTIALLY EQUIVALENT 1
WRP ASIA PACIFIC
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Reaction 1
Total Device Problems 1

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 1 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ansell Healthcare Products LLC II Aug-31-2011
2 Integra Pain Management II Sep-20-2008

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