K171213 is an FDA 510(k) clearance for the One Touch Condom with Benzocaine. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Thai Nippon Rubber Industry Public Company Limited. (Bangkok, TH). The FDA issued a Cleared decision on January 12, 2018, 262 days after receiving the submission on April 25, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K171213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2017 |
| Decision Date | January 12, 2018 |
| Days to Decision | 262 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 |