K222611 is an FDA 510(k) clearance for the Male Latex Condoms, a Condom (Class II — Special Controls, product code HIS), submitted by Suzhou Colour-Way New Material Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 28, 2022, 90 days after receiving the submission on August 30, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K222611 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 2022 |
| Decision Date | November 28, 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 |