HIS · Condom
Obstetrics/Gynecology · 21 CFR 884.5300 · Class 2
Overview
| Product Code | HIS |
|---|---|
| Device Name | Condom |
| 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 400)
Showing 20 most recent of 400 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | Nov 18, 2025 | SESE |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | Jul 11, 2025 | SESE |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | Mar 7, 2025 | SESE |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. | Feb 21, 2025 | SESE |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | Feb 18, 2025 | SESE |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | Oct 5, 2023 | SESE |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | Ttk Healthcare Limited | Sep 7, 2023 | SESE |
| K222611 | Male Latex Condoms | Suzhou Colour-Way New Material Co., Ltd. | Nov 28, 2022 | SESE |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | Nov 7, 2022 | SESE |
| K222068 | Durex Penck III Regular | Rb Health (Us), LLC | Oct 12, 2022 | SESE |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | Church & Dwight Co., Inc. | Sep 28, 2022 | SESE |
| K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | Aug 5, 2022 | SESE |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | Church & Dwight Co., Inc. | Jul 14, 2022 | SESE |
| K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | May 11, 2022 | SESE |
| K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | Apr 28, 2022 | SESE |
| K213647 | Durex Patronus Wide | Rb Health (Us), LLC | Feb 17, 2022 | SESE |
| K210208 | Titan Condoms | Titan Condoms, LLC | Feb 17, 2022 | SESE |
| K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla | Ttk Healthcare Limited | Dec 23, 2021 | SESE |
| K211450 | Playboy 3 Contour Condom | Thai Nippon Rubber Industry Public Company Limited. | Sep 30, 2021 | SESE |
| K210294 | One Touch Spiral Condom | Thai Nippon Rubber Industry Public Company Limited. | Sep 23, 2021 | SESE |
Top Applicants
- Carter Products — 15 clearances
- Mayer Laboratories — 13 clearances
- Okamoto USA, Inc. — 13 clearances
- Ansell, Inc. — 12 clearances
- Church & Dwight Co., Inc. — 12 clearances
