510(k) K250502 ยท LZA Polymer Patient Examination Glove
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
| Applicant | Safesource Direct, LLC, Broussard LA, US |
| Decision | Substantially Equivalent, Mar 19, 2025 |
| Received | Feb 20, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250502
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.