510(k) K252622 ยท HIS Condom
Male Latex Condom HA
| Applicant | Okamoto USA, Inc., Sandusky OH, US |
| Decision | Substantially Equivalent, May 4, 2026 |
| Received | Aug 19, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K252622
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.