K222068 is an FDA 510(k) clearance for the Durex Penck III Regular. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Rb Health (Us), LLC (Parsippany, US). The FDA issued a Cleared decision on October 12, 2022, 90 days after receiving the submission on July 14, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K222068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2022 |
| Decision Date | October 12, 2022 |
| Days to Decision | 90 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 |