ClearanceBrief
510(k) K231643 ยท LZA Polymer Patient Examination Glove

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

ApplicantSyntex Healthcare Products Co., Ltd., Xinji, CN
DecisionSubstantially Equivalent, Sep 8, 2023
ReceivedJun 5, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231643

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.