FDA 510(k) Applications for Medical Device Product Code: MOL (Condom, Synthetic)

FDA 510(k) Applications for Medical Device Product Code "MOL"
(Condom, Synthetic)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K070800	ANSELL HEALTHCARE PRODUCTS LLC	LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM	03/06/2008
K171172	Ansell Healthcare Products LLC.	Skyn Original Polyisoprene Lubricated Male Condom - Flavored	08/02/2017
K160399	Ansell Healthcare Products, LLC	Skyn Original Polyisoprene Lubricated Male Condom	07/25/2016
K955672	CARTER PRODUCTS	TROJAN POLYURETHANE CONDOM (MODIFICATION)	08/29/1996
K240379	Church & Dwight Co., Inc.	TROJAN SIS Synthetic Latex Condom with Silicone Lubricant	10/08/2024
K050828	CHURCH & DWIGHT CO., INC.	TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM	02/28/2006
K100767	CHURCH & DWIGHT CO., INC.	TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM	04/05/2011
K171639	Church & Dwight Co., Inc.	Trojan Supra Lubricated Polyurethane Male Condom	08/01/2017
K962816	GENX INTL., INC.	SPERM PREPARATION MEDIA	11/26/1996
K240896	Global Protection Corp.	ONE Nitrile Condom	08/23/2024
K243967	Global Protection Corp.	ONE Nitrile Condom	04/08/2025
K001974	MAYER LABORATORIES	EZ-ON CONDOM	10/24/2001
K203541	Okamoto U.S.A. Inc.	Okamoto 002 Lubricated Polyurethane Male Condom	02/25/2022
K241617	RB Health (US) LLC	Durex Polyisoprene Condom	02/28/2025
K974121	SENSICON CORP.	LUBRICATED BAGGY TACTYLON CONDOM	01/29/1998
K971590	SENSICON CORP.	TACTYLON CONDOM	10/07/1997
K072169	SSL AMERICAS, INC.	DUREX SYNTHETIC POLYISOPRENE MALE CONDOM	06/19/2008
K231908	Suretex Limited	45 Micron Polyisoprene Condom	10/27/2023
K232470	Suretex Limited	Polyisoprene Extra Large Condom	05/09/2024
K182438	Sxwell Usa LLC	Synthetic Polyisoprene Lubricated Male Condom - 5 senses	12/06/2018

FDA 510(k) Applications for Medical Device Product Code "MOL" (Condom, Synthetic)

FDA 510(k) Applications for Medical Device Product Code "MOL"
(Condom, Synthetic)