510(k) K214074 ยท KGO Surgeon'S Gloves
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
| Applicant | Hartalega NGC Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, May 26, 2022 |
| Received | Dec 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214074
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.