510(k) K043508 ยท KGO Surgeon'S Gloves
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
| Applicant | Ansell Healthcare Products, LLC, Dothan AL, US |
| Decision | Substantially Equivalent, Jan 19, 2005 |
| Received | Dec 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043508
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.