510(k) K252158 ยท MOL Condom, Synthetic
Sagami Original 002 Polyurethane Male Condom
| Applicant | Mayer Laboratories, Berkeley CA, US |
| Decision | Substantially Equivalent, Mar 30, 2026 |
| Received | Jul 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252158
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.