510(k) K260794 ยท LZA Polymer Patient Examination Glove
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
| Applicant | Kossan International Sdn Bhd, Shah Alam, MY |
| Decision | Substantially Equivalent, Aug 18, 2026 |
| Received | Mar 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260794
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.