510(k) K171375 ยท KGO Surgeon'S Gloves
Gammex PI Breach Detect Powder Free Surgical Glove
| Applicant | Ansell Healthcare Products, LLC, Iselin NJ, US |
| Decision | Substantially Equivalent, Feb 6, 2018 |
| Received | May 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171375
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.