510(k) K201748 ยท KGO Surgeon'S Gloves
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
| Applicant | Hartalega Sdn Bhd, Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Oct 2, 2020 |
| Received | Jun 26, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201748
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.