HIS — Condom Class II
FDA Device Classification
Classification Details
- Product Code
- HIS
- Device Class
- Class II
- Regulation Number
- 884.5300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252521 | suretex limited | LifeStyles® HydraFeel Natural Rubber Latex Condom | November 18, 2025 |
| K250034 | shaoguan regenex pharmaceuticals co | Natural rubber latex male condom | July 11, 2025 |
| K243421 | lelo | Lelo Hex Lubricated Natural Rubber Latex Condom | March 7, 2025 |
| K243640 | church and dwight co | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed E | February 21, 2025 |
| K243584 | okamoto usa | 0.04 ZERO ZERO FOUR Male Latex Condom | February 18, 2025 |
| K232279 | suretex limited | LifeStyles NRL Textured Condom | October 5, 2023 |
| K230049 | ttk healthcare limited | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE | September 7, 2023 |
| K222611 | suzhou colour-way new material co | Male Latex Condoms | November 28, 2022 |
| K220489 | rb health (us) | Durex Patronus CloseFit, Durex Patronus Regular | November 7, 2022 |
| K222068 | rb health (us) | Durex Penck III Regular | October 12, 2022 |
| K221906 | church and dwight co | TROJAN Fire & Ice lubricated male natural rubber latex condom | September 28, 2022 |
| K220576 | shanghai personage hygiene products co | FAMA Male Latex Condoms | August 5, 2022 |
| K221431 | church and dwight co | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lu | July 14, 2022 |
| K211152 | rb health (us) | Durex Condom with Benzocaine | May 11, 2022 |
| K213921 | suretex limited | Microthin Natural Rubber Latex Condom | April 28, 2022 |
| K213647 | rb health (us) | Durex Patronus Wide | February 17, 2022 |
| K210208 | titan condoms | Titan Condoms | February 17, 2022 |
| K213547 | ttk healthcare limited | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vani | December 23, 2021 |
| K211450 | thai nippon rubber industry public company limited | Playboy 3 Contour Condom | September 30, 2021 |
| K210294 | thai nippon rubber industry public company limited | One Touch Spiral Condom | September 23, 2021 |