K243584 is an FDA 510(k) clearance for the 0.04 ZERO ZERO FOUR Male Latex Condom, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Sandusky, US). The FDA issued a Cleared decision on February 18, 2025, 90 days after receiving the submission on November 20, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K243584 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 2024 |
| Decision Date | February 18, 2025 |
| Days to Decision | 90 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 |