510(k) K211540 ยท LZA Polymer Patient Examination Glove
Edma Synthetic Nitrile Examination Gloves
| Applicant | Edma Group, LLC, Phoenix AZ, US |
| Decision | Substantially Equivalent, Aug 9, 2021 |
| Received | May 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211540
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.