510(k) K190466 ยท LZA Polymer Patient Examination Glove
PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
| Applicant | Shen Wei USA, Inc., Union City CA, US |
| Decision | Substantially Equivalent, Sep 26, 2019 |
| Received | Feb 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190466
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.