MOL
- Product code
- MOL
- Device name
- Condom, Synthetic
- 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
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 23 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252158 | 2026-03-30 | Mayer Laboratories | Sagami Original 002 Polyurethane Male Condom | |
| K243967 | 2025-04-08 | Global Protection Corp. | ONE Nitrile Condom | — |
| K241617 | 2025-02-28 | Rb Health (Us), LLC | Durex Polyisoprene Condom | — |
| K240379 | 2024-10-08 | Church & Dwight Co., Inc. | TROJAN SIS Synthetic Latex Condom with Silicone Lubr… | |
| K240896 | 2024-08-23 | Global Protection Corp. | ONE Nitrile Condom | — |
| K232470 | 2024-05-09 | Suretex Limited | Polyisoprene Extra Large Condom | |
| K231908 | 2023-10-27 | Suretex Limited | 45 Micron Polyisoprene Condom |
Official FDA classification page: MOL
Classification and pathway per current FDA publications. Data from openFDA (CC0).