MOL · Class II · 21 CFR 884.5300

FDA Product Code MOL: Condom, Synthetic

Leading manufacturers include Church & Dwight Co., Inc., Ansell Healthcare Products, LLC and Suretex Limited.

22
Total
22
Cleared
273d
Avg days
1995
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg 206d recently vs 283d historically

FDA 510(k) Cleared Condom, Synthetic Devices (Product Code MOL)

22 devices
1–22 of 22
Cleared Apr 08, 2025
ONE Nitrile Condom
K243967
Global Protection Corp.
Obstetrics & Gynecology · 106d
Cleared Feb 28, 2025
Durex Polyisoprene Condom
K241617
Rb Health (Us), LLC
Obstetrics & Gynecology · 268d
Cleared Oct 08, 2024
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
K240379
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 244d
Cleared Aug 23, 2024
ONE Nitrile Condom
K240896
Global Protection Corp.
Obstetrics & Gynecology · 144d
Cleared May 09, 2024
Polyisoprene Extra Large Condom
K232470
Suretex Limited
Obstetrics & Gynecology · 267d
Cleared Oct 27, 2023
45 Micron Polyisoprene Condom
K231908
Suretex Limited
Obstetrics & Gynecology · 120d
Cleared Feb 25, 2022
Okamoto 002 Lubricated Polyurethane Male Condom
K203541
Okamoto USA, Inc.
Obstetrics & Gynecology · 449d
Cleared Dec 06, 2018
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
K182438
Sxwell USA, LLC
Obstetrics & Gynecology · 90d
Cleared Aug 02, 2017
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
K171172
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 103d
Cleared Aug 01, 2017
Trojan Supra Lubricated Polyurethane Male Condom
K171639
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 60d
Cleared Jul 25, 2016
Skyn Original Polyisoprene Lubricated Male Condom
K160399
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 164d
Cleared Apr 05, 2011
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K100767
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 383d
Cleared Mar 06, 2008
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K070800
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 349d
Cleared Feb 28, 2006
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K050828
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 333d
Cleared Oct 24, 2001
EZ-ON CONDOM
K001974
Mayer Laboratories
Obstetrics & Gynecology · 482d
Cleared Jan 29, 1998
LUBRICATED BAGGY TACTYLON CONDOM
K974121
Sensicon Corp.
Obstetrics & Gynecology · 90d
Cleared Oct 07, 1997
TACTYLON CONDOM
K971590
Sensicon Corp.
Obstetrics & Gynecology · 159d
Cleared Nov 26, 1996
SPERM PREPARATION MEDIA
K962816
Intl., Inc.
Obstetrics & Gynecology · 130d
Cleared Aug 29, 1996
TROJAN POLYURETHANE CONDOM (MODIFICATION)
K955672
Carter Products
Obstetrics & Gynecology · 302d
Cleared Jun 22, 1995
TROJAN POLYURETHANE CONDOM
K942697
Carter Products
Obstetrics & Gynecology · 379d

About Product Code MOL - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code MOL since 1995, with 22 receiving FDA clearance (average review time: 273 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - MOL Product Code

Recent submissions under MOL have taken an average of 206 days to reach a decision - down from 283 days historically, suggesting improved FDA processing for this classification.

MOL devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →