510(k) Report

Devices descending from K902696

10 later devices reach N-DEX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992170N-Dex Blue Powder-Free Nitrile Medical Examination GloveBest Manufacturing Company19998—
+1K970135Nitrile GlovesSage Products, Inc.19970—
+2K030075Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured)Best Manufacturing Company-Distribution Center20030—
+2K012899Green Nitrile Powder-Free Medical Exmaination GloveBest Manufacturing Company20014—
+2K012166Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company20012—
+2K993805Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves (Blue, Cherry Flavored)Best Manufacturing Company20000—
+3K082125N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFTBest Glove, Inc.20082—
+3K022024Nitrile Powder-Free Medical Examination Glove (Green)Best Manufacturing Company20020—
+4K190159Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile gloveShowa Best Glove, Inc.20191—
+5K252075Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC20250—