K163107 is an FDA 510(k) clearance for the Lifestyles Zero Lubricated Latex Male Condom. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Ansell Healthcare Products, LLC (Iselin, US). The FDA issued a Cleared decision on January 23, 2017, 77 days after receiving the submission on November 7, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K163107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2016 |
| Decision Date | January 23, 2017 |
| Days to Decision | 77 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 |