ClearanceBrief
510(k) K252549 ยท LZA Polymer Patient Examination Glove

Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentany

ApplicantKossan International Sdn Bhd, Shah Alam, MY
DecisionSubstantially Equivalent, Jan 13, 2026
ReceivedAug 13, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252549

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.