K221431 is an FDA 510(k) clearance for the TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on July 14, 2022, 58 days after receiving the submission on May 17, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K221431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2022 |
| Decision Date | July 14, 2022 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIS — Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |