510(k) Report

Devices descending from K090828

5 later devices reach Non-Sterile, Powder Free Nitrile Examination Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103675Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd.20110—
+1K110960Royal Imperial Nitrile Examination Gloves Textured Powder-FreeKoon Seng Sdn Bhd20110—
+1K101870Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd.20101—
+1K093517Nitritech or Multiple Private Label Non-Sterile Powder Free Nitrile Patient Examination…Summit Glove, Inc.20100—
+1K093516Nitritech or Multiple Private Label Non Sterile Powdered Nitrile Examination GlovesSummit Glove, Inc.20100—