510(k) K213141 ยท LZA Polymer Patient Examination Glove
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, 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, May 28, 2022 |
| Received | Sep 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213141
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.