ClearanceBrief
510(k) K163126 ยท LZA Polymer Patient Examination Glove

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)

ApplicantBlue Sail Medical Co.,Ltd, Zibo, CN
DecisionSubstantially Equivalent, Feb 22, 2017
ReceivedNov 8, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163126

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.