510(k) Report

Devices descending from K082125

2 later devices reach N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190159Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile gloveShowa Best Glove, Inc.20191—
+2K252075Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC20250—