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
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
K001974 MAYER LABORATORIES EZ-ON CONDOM 10/24/2001
K203541 Okamoto U.S.A. Inc. Okamoto 002 Lubricated Polyurethane Male Condom 02/25/2022
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
K182438 Sxwell Usa LLC Synthetic Polyisoprene Lubricated Male Condom - 5 senses 12/06/2018


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