510(k) K160928 ยท KGO Surgeon'S Gloves
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)
| Applicant | Hartalega Sdb. Bhd., Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Dec 20, 2016 |
| Received | Apr 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160928
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.