Product Code: MOL FDA class 2 21 CFR 884.5300

Condom, Synthetic

Obstetrics/Gynecology

The Synthetic Condom is an obstetrics/gynecology device used as a barrier contraceptive made from synthetic materials (other than latex), providing protection against pregnancy and sexually transmitted infections. Classified as FDA Class 2 under 21 CFR 884.5300, it requires 510(k) premarket notification. The product code is MOL, and it is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MOL
Device Class: FDA class 2
Regulation Number: 884.5300
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252158	Sagami Original 002 Polyurethane Male Condom	Mar 30, 2026	Substantially Equivalent	Mayer Laboratories
K243967	ONE Nitrile Condom	Apr 08, 2025	Substantially Equivalent	Global Protection Corp.
K241617	Durex Polyisoprene Condom	Feb 28, 2025	Substantially Equivalent	Rb Health (Us), LLC
K240379	TROJAN SIS Synthetic Latex Condom with Silicone Lubricant	Oct 08, 2024	Substantially Equivalent	Church & Dwight Co., Inc.
K240896	ONE Nitrile Condom	Aug 23, 2024	Substantially Equivalent	Global Protection Corp.
K232470	Polyisoprene Extra Large Condom	May 09, 2024	Substantially Equivalent	Suretex Limited
K231908	45 Micron Polyisoprene Condom	Oct 27, 2023	Substantially Equivalent	Suretex Limited
K203541	Okamoto 002 Lubricated Polyurethane Male Condom	Feb 25, 2022	Substantially Equivalent	Okamoto USA, Inc.
K182438	Synthetic Polyisoprene Lubricated Male Condom - 5 senses	Dec 06, 2018	Substantially Equivalent	Sxwell USA, LLC
K171172	Skyn Original Polyisoprene Lubricated Male Condom - Flavored	Aug 02, 2017	Substantially Equivalent	Ansell Healthcare Products, LLC
K171639	Trojan Supra Lubricated Polyurethane Male Condom	Aug 01, 2017	Substantially Equivalent	Church & Dwight Co., Inc.
K160399	Skyn Original Polyisoprene Lubricated Male Condom	Jul 25, 2016	Substantially Equivalent	Ansell Healthcare Products, LLC
K100767	TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM	Apr 05, 2011	Substantially Equivalent	Church & Dwight Co., Inc.
K072169	DUREX SYNTHETIC POLYISOPRENE MALE CONDOM	Jun 19, 2008	Substantially Equivalent	Ssl Americas, Inc.
K070800	LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM	Mar 06, 2008	Substantially Equivalent	Ansell Healthcare Products, LLC
K050828	TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM	Feb 28, 2006	Substantially Equivalent	Church & Dwight Co., Inc.
K001974	EZ-ON CONDOM	Oct 24, 2001	Substantially Equivalent	Mayer Laboratories
K974121	LUBRICATED BAGGY TACTYLON CONDOM	Jan 29, 1998	Substantially Equivalent	Sensicon Corp.
K971590	TACTYLON CONDOM	Oct 07, 1997	Substantially Equivalent	Sensicon Corp.
K962816	SPERM PREPARATION MEDIA	Nov 26, 1996	Substantially Equivalent	Genx Intl., Inc.
K955672	TROJAN POLYURETHANE CONDOM (MODIFICATION)	Aug 29, 1996	Substantially Equivalent	Carter Products
K942697	TROJAN POLYURETHANE CONDOM	Jun 22, 1995	Substantially Equivalent	Carter Products
K922688	EXTRA PROTECTION POLYURETHANE CONDOM	May 04, 1995	Substantially Equivalent	Apex Medical Technologies, Inc.