ClearanceBrief
510(k) K243133 ยท LZA Polymer Patient Examination Glove

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

ApplicantKl-Kepong Rubber Products Sdn. Bhd., Ipoh, MY
DecisionSubstantially Equivalent, Jun 17, 2025
ReceivedSep 30, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243133

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.