ClearanceBrief
510(k) K260312 ยท LZA Polymer Patient Examination Glove

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

ApplicantGmp Medicare Sdn. Bhd., Klang, MY
DecisionSubstantially Equivalent, Sep 8, 2026
ReceivedJan 30, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K260312

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.