510(k) K151694 ยท KGO Surgeon'S Gloves
Gammex PI Hybrid Surgical Gloves
| Applicant | Ansell Healthcare Products, LLC, Iselin NJ, US |
| Decision | Substantially Equivalent, Mar 9, 2016 |
| Received | Jun 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151694
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.