MOL · Condom, Synthetic
Obstetrics/Gynecology · 21 CFR 884.5300 · Class 2
Overview
| Product Code | MOL |
|---|---|
| Device Name | Condom, Synthetic |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Classification Rationale
(1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | Mar 30, 2026 | SESE |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | Apr 8, 2025 | SESE |
| K241617 | Durex Polyisoprene Condom | Rb Health (Us), LLC | Feb 28, 2025 | SESE |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | Oct 8, 2024 | SESE |
| K240896 | ONE Nitrile Condom | Global Protection Corp. | Aug 23, 2024 | SESE |
| K232470 | Polyisoprene Extra Large Condom | Suretex Limited | May 9, 2024 | SESE |
| K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | Oct 27, 2023 | SESE |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Okamoto USA, Inc. | Feb 25, 2022 | SESE |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | Dec 6, 2018 | SESE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | Aug 2, 2017 | SESE |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | Aug 1, 2017 | SESE |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | Jul 25, 2016 | SESE |
| K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | Apr 5, 2011 | SESE |
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | Ssl Americas, Inc. | Jun 19, 2008 | SESE |
| K070800 | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM | Ansell Healthcare Products, LLC | Mar 6, 2008 | SESE |
| K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | Feb 28, 2006 | SESE |
| K001974 | EZ-ON CONDOM | Mayer Laboratories | Oct 24, 2001 | SESE |
| K974121 | LUBRICATED BAGGY TACTYLON CONDOM | Sensicon Corp. | Jan 29, 1998 | SESE |
| K971590 | TACTYLON CONDOM | Sensicon Corp. | Oct 7, 1997 | SESE |
| K962816 | SPERM PREPARATION MEDIA | Genx Intl., Inc. | Nov 26, 1996 | SESE |
Top Applicants
- Church & Dwight Co., Inc. — 4 clearances
- Ansell Healthcare Products, LLC — 3 clearances
- Carter Products — 2 clearances
- Global Protection Corp. — 2 clearances
- Mayer Laboratories — 2 clearances
