K081886 is an FDA 510(k) clearance for the KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED. 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 February 6, 2009, 219 days after receiving the submission on July 2, 2008.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K081886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2008 |
| Decision Date | February 06, 2009 |
| Days to Decision | 219 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIS - Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |