510(k) K250342 ยท LZA Polymer Patient Examination Glove
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
| Applicant | Encompass Industries Sdn. Bhd., Kemaman, MY |
| Decision | Substantially Equivalent, Jul 8, 2025 |
| Received | Feb 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250342
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.