510(k) K183536 ยท KGO Surgeon'S Gloves
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
| Applicant | Hartalega NGC Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | Dec 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183536
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.