510(k) Report

Devices descending from K193666

1 later device reach Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with…Glove One, LLC20250—