510(k) K243796 · LZA Polymer Patient Examination Glove
GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
| Applicant | Glove One, LLC, Mooresville NC, US |
| Decision | Substantially Equivalent, Jun 3, 2025 |
| Received | Dec 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243796
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.