510(k) K240545 · LZA Polymer Patient Examination Glove
GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
| Applicant | Genabio Diagnostics, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Aug 28, 2024 |
| Received | Feb 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240545
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.