510(k) K250034 ยท HIS Condom
Natural rubber latex male condom
| Applicant | Shaoguan Regenex Pharmaceuticals Co., Ltd., Shaoguan, CN |
| Decision | Substantially Equivalent, Jul 11, 2025 |
| Received | Jan 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250034
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.