510(k) K211758 ยท OPC Powder-Free Polychloroprene Patient Examination Glove
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
| Applicant | Hartalega NGC Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Aug 3, 2021 |
| Received | Jun 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211758
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.