510(k) K053442 ยท KGO Surgeon'S Gloves
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
| Applicant | Regent Medical Americas, LLC, Norcross GA, US |
| Decision | Substantially Equivalent, Mar 7, 2006 |
| Received | Dec 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053442
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.