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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lubricant, personal
Regulation Description Condom.
Definition This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
Product CodeNUC
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
BIOFILM, INC.
  SUBSTANTIALLY EQUIVALENT 3
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 5
DLC LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FIDIA FARMACEUTICI SPA
  SUBSTANTIALLY EQUIVALENT 2
INSTEAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
JULIE WILLIAMS, PA-C
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MCNEIL-PPC, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
PERSONAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 2
PHARMAPAC LLC
  SUBSTANTIALLY EQUIVALENT 3
SSL
  SUBSTANTIALLY EQUIVALENT 5
THAI NIPPON RUBBER INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOPCO SALES
  SUBSTANTIALLY EQUIVALENT 1
WISCONSIN PHARMACAL CO., LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 5
Total Device Problems 5

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 2 0 0 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 INGfertility, LLC II Jan-23-2009
2 Mc-NEIL-PPC, Inc. II Feb-22-2013
3 Mc-NEIL-PPC, Inc. II Sep-27-2012
4 Memphis Fertility Laboratory Inc II Aug-27-2009

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