510(k) K053443 ยท KGO Surgeon'S Gloves
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
| Applicant | Regent Medical Americas, LLC, Norcross GA, US |
| Decision | Substantially Equivalent, Feb 1, 2006 |
| Received | Dec 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053443
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.