K132597 is an FDA 510(k) clearance for the BLACK COLOURED CONDOM. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Karex Industries Sdn. Bhd. (Pontian Kecil, Jalan Johor, MY). The FDA issued a Cleared decision on November 25, 2013, 98 days after receiving the submission on August 19, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K132597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2013 |
| Decision Date | November 25, 2013 |
| Days to Decision | 98 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIS - Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |