K231908 is an FDA 510(k) clearance for the 45 Micron Polyisoprene Condom. This device is classified as a Condom, Synthetic (Class II - Special Controls, product code MOL).
Submitted by Suretex Limited (Tambon Khao Kwai, Amphur Phunphin, TH). The FDA issued a Cleared decision on October 27, 2023, 120 days after receiving the submission on June 29, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K231908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MOL - Condom, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |