510(k) K243818 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
| Applicant | Hartalega NGC Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Jan 8, 2025 |
| Received | Dec 12, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243818
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.