K243967 is an FDA 510(k) clearance for the ONE Nitrile Condom. This device is classified as a Condom, Synthetic (Class II - Special Controls, product code MOL).
Submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on April 8, 2025, 106 days after receiving the submission on December 23, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K243967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2024 |
| Decision Date | April 08, 2025 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MOL - Condom, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |