510(k) K230578 ยท KGO Surgeon'S Gloves
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
| Applicant | Wrp Asia Pacific Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Aug 31, 2023 |
| Received | Mar 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230578
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.