510(k) K213289 · KGO Surgeon'S Gloves
Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs
| Applicant | Ansell Healthcare Products, LLC, Reno NV, US |
| Decision | Substantially Equivalent, May 26, 2023 |
| Received | Oct 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213289
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.