K250034 is an FDA 510(k) clearance for the Natural rubber latex male condom. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Shaoguan Regenex Pharmaceuticals Co., Ltd. (Shaoguan, CN). The FDA issued a Cleared decision on July 11, 2025, 185 days after receiving the submission on January 7, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K250034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2025 |
| Decision Date | July 11, 2025 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIS - Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |