510(k) K231902 ยท KGO Surgeon'S Gloves
GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
| Applicant | Ansell Healthcare, Reno NV, US |
| Decision | Substantially Equivalent, Oct 20, 2023 |
| Received | Jun 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231902
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.