510(k) K183389 ยท KGO Surgeon'S Gloves
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
| Applicant | Hartalega NGC Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Jun 28, 2019 |
| Received | Dec 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183389
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.