TPLC - Total Product Life Cycle

• Device: condom
• Regulation Description: Condom.
• Product Code: HIS
• Regulation Number: 884.5300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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	5
DAILIAN LATEX COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOLATEX SDN. BHD
	SUBSTANTIALLY EQUIVALENT	8
KAREX INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
NULATEX SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
OKAMOTO
	SUBSTANTIALLY EQUIVALENT	9
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
Material rupture	1
Split	1
Total Device Problems	2

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