TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ALATECH HEALTHCARE, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ANSELL HEALTHCARE PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ANSELL HEATHCARE PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
CHURCH & DWIGHT CO., INC
	SUBSTANTIALLY EQUIVALENT	1
CHURCH & DWIGHT CO., INC.
	SUBSTANTIALLY EQUIVALENT	6
CHURCH & DWIGHT CO.,INC.
	SUBSTANTIALLY EQUIVALENT	1
CHURCH & DWIGHT VIRGINIA CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
CUPID LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL MAILER PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU DAMING UNITED RUBBER PRODUCTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANKOOK LATEX GONGUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLENDER SUSTAINABLE BRANDS LLC
	SUBSTANTIALLY EQUIVALENT	1
INNOLATEX (THAILAND) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
KAREX INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
KAREX INDUSTRIES SDN BHD.
	SUBSTANTIALLY EQUIVALENT	1
LELO INC.
	SUBSTANTIALLY EQUIVALENT	2
M3 GLOBAL ENTERPRISES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MAPA GMBH
	SUBSTANTIALLY EQUIVALENT	1
MAYER LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL-LATEX (DUA) SDN. BHD
	SUBSTANTIALLY EQUIVALENT	1
NULATEX SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
O-RING PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
OKAMOTO U.S.A., INC.
	SUBSTANTIALLY EQUIVALENT	4
PROFILATEX, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
RB HEALTH (US) LLC
	SUBSTANTIALLY EQUIVALENT	5
SHANGHAI PERSONAGE HYGIENE PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHEILA PICKERING PH.D.
	SUBSTANTIALLY EQUIVALENT	1
SURETEX LIMITED
	SUBSTANTIALLY EQUIVALENT	2
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THAI NIPPON RUBBER INDUSTRY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	3
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LTD
	SUBSTANTIALLY EQUIVALENT	1
THEYFIT
	SUBSTANTIALLY EQUIVALENT	2
TITAN CONDOMS LLC
	SUBSTANTIALLY EQUIVALENT	1
TTK HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	3
TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG XIANGBAN LATEX PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	16	16
2015	8	8
2016	5	5
2017	8	8
2018	11	11
2019	15	15
2020	12	12
2021	16	16
2022	18	18
2023	9	9

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	Family Dollar Stores, Llc.	II	Aug-17-2022
4	Reckitt Benckiser LLC	II	Feb-23-2017