510(k) Report

Devices descending from K210057

2 later devices reach Blue Nitrile Exam Glove, Powder Free through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211319Purism Non-Sterile Powder Free Nitrile Examination GlovesDezhou Purism Medical Technology Co., Ltd.20211—
+2K213688Nitrile Examination Gloves (Model: ZMG1351)Wuhan Zonsen Medical Products Co., Ltd.20220—