510(k) K213142 ยท LZA Polymer Patient Examination Glove
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
| Applicant | Shen Wei USA, Inc., Union City CA, US |
| Decision | Substantially Equivalent, Jan 28, 2022 |
| Received | Sep 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213142
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.