K232470 is an FDA 510(k) clearance for the Polyisoprene Extra Large Condom. This device is classified as a Condom, Synthetic (Class II - Special Controls, product code MOL).
Submitted by Suretex Limited (Suratthani, TH). The FDA issued a Cleared decision on May 9, 2024, 267 days after receiving the submission on August 16, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K232470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2023 |
| Decision Date | May 09, 2024 |
| Days to Decision | 267 days |
| Submission Type | Abbreviated |
| 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 |