510(k) K211547 ยท LZA Polymer Patient Examination Glove
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
| Applicant | Edma Group, LLC, Phoenix AZ, US |
| Decision | Substantially Equivalent, Jul 15, 2021 |
| Received | May 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211547
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.