510(k) K243967 ยท MOL Condom, Synthetic
ONE Nitrile Condom
| Applicant | Global Protection Corp., Boston MA, US |
| Decision | Substantially Equivalent, Apr 8, 2025 |
| Received | Dec 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243967
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.