510(k) Report

Devices descending from K143289

4 later devices reach Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222721Violet Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited20220—
+1K220121Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and BlackAamedix Glove Sdn Bhd20220—
+1K210388Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black colorMexpo International, Inc.20210—
+1K210587Violet Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd20210—