K252158
- 510(k) number
- K252158
- Device name
- Sagami Original 002 Polyurethane Male Condom
- Applicant
- Mayer Laboratories CA · US
- Product code
- MOL — Condom, Synthetic
- Decision date
- 2026-03-30
- Date received
- 2025-07-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252158.pdf
Official FDA record: K252158
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.