510(k) K200897 ยท KGO Surgeon'S Gloves
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
| Applicant | Hartalega Sdn Bhd, Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Jun 1, 2020 |
| Received | Apr 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200897
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.