K070800 is an FDA 510(k) clearance for the LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM. This device is classified as a Condom, Synthetic (Class II - Special Controls, product code MOL).
Submitted by Ansell Healthcare Products, LLC (Dothan, US). The FDA issued a Cleared decision on March 6, 2008, 349 days after receiving the submission on March 23, 2007.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K070800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2007 |
| Decision Date | March 06, 2008 |
| Days to Decision | 349 days |
| Submission Type | Abbreviated |
| 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 |