K131887 is an FDA 510(k) clearance for the TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on October 24, 2013, 121 days after receiving the submission on June 25, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K131887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2013 |
| Decision Date | October 24, 2013 |
| Days to Decision | 121 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 |