K211450 is an FDA 510(k) clearance for the Playboy 3 Contour Condom. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Thai Nippon Rubber Industry Public Company Limited. (Sriracha, TH). The FDA issued a Cleared decision on September 30, 2021, 143 days after receiving the submission on May 10, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K211450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2021 |
| Decision Date | September 30, 2021 |
| Days to Decision | 143 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 |