K050828 is an FDA 510(k) clearance for the TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM. This device is classified as a Condom, Synthetic (Class II - Special Controls, product code MOL).
Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on February 28, 2006, 333 days after receiving the submission on April 1, 2005.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K050828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2005 |
| Decision Date | February 28, 2006 |
| Days to Decision | 333 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 |