K252622
- 510(k) number
- K252622
- Device name
- Male Latex Condom HA
- Applicant
- Okamoto USA, Inc. OH · US
- Product code
- HIS — Condom
- Decision date
- 2026-05-04
- Date received
- 2025-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252622.pdf
Official FDA record: K252622
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.