510(k) Report

Devices descending from K070639

1 later device reach Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc.20160—