HIS
- Product code
- HIS
- Device name
- Condom
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 401 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252622 | 2026-05-04 | Okamoto USA, Inc. | Male Latex Condom HA | |
| K252521 | 2025-11-18 | Suretex Limited | LifeStyles® HydraFeel Natural Rubber Latex Condom | |
| K250034 | 2025-07-11 | Shaoguan Regenex Pharmaceuticals Co., … | Natural rubber latex male condom | — |
| K243421 | 2025-03-07 | Lelo, Inc. | Lelo Hex Lubricated Natural Rubber Latex Condom | |
| K243640 | 2025-02-21 | Church & Dwight Co., Inc. | Trojan Ultra Ribbed Ecstasy latex condom with lubri… | |
| K243584 | 2025-02-18 | Okamoto USA, Inc. | 0.04 ZERO ZERO FOUR Male Latex Condom | |
| K232279 | 2023-10-05 | Suretex Limited | LifeStyles NRL Textured Condom | FDA |
Official FDA classification page: HIS
Classification and pathway per current FDA publications. Data from openFDA (CC0).