510(k) K260867 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
| Applicant | Hartalega NGC Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Jun 17, 2026 |
| Received | Mar 17, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260867
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.