K024324 is an FDA 510(k) clearance for the LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on March 25, 2003, 89 days after receiving the submission on December 26, 2002.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K024324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2002 |
| Decision Date | March 25, 2003 |
| Days to Decision | 89 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 |