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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device condom
Regulation Description Condom.
Product CodeHIS
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
ALATECH HEALTHCARE, LLC.
  SUBSTANTIALLY EQUIVALENT 2
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 14
APEX
  SUBSTANTIALLY EQUIVALENT 3
BIOFILM, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOGREEN MEDICAL SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 6
DAILIAN LATEX COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOLATEX SDN. BHD
  SUBSTANTIALLY EQUIVALENT 8
KAREX INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 5
NULATEX SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 3
OKAMOTO
  SUBSTANTIALLY EQUIVALENT 11
PROFILATEX, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
RICHTER RUBBER TECHNOLOGY SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
SSL
  SUBSTANTIALLY EQUIVALENT 7
SURETEX, LTD.
  SUBSTANTIALLY EQUIVALENT 5
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
TIANJIN HUMAN-CARE LATEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIDUS CORP.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Break 2
Material rupture 1
Split 1
Total Device Problems 4

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 1 0 0 0 0 0 2 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 Feb-20-2013
2 Ansell Healthcare Products LLC II Jan-24-2013
3 Global Protection Corp. II Dec-11-2007

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