510(k) K221164 ยท LZA Polymer Patient Examination Glove
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
| Applicant | Hong Seng Gloves Sdn Bhd, Sungai Petani, MY |
| Decision | Substantially Equivalent, Aug 30, 2022 |
| Received | Apr 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221164
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.