ClearanceBrief
510(k) K243604 ยท LZA Polymer Patient Examination Glove

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

ApplicantO&M Halyard, Inc., Alpharetta GA, US
DecisionSubstantially Equivalent, Aug 18, 2025
ReceivedNov 21, 2024
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K243604

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.