510(k) K182948 ยท KGO Surgeon'S Gloves
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
| Applicant | Ansell Healthcare Products, LLC, Reno NV, US |
| Decision | Substantially Equivalent, Mar 22, 2019 |
| Received | Oct 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182948
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.