510(k) Report

Devices descending from K111248

4 later devices reach Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211810Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy…Pt. Shamrock Manufacturing Corpora20221—
+1K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and…Medline Industries, Inc.20201—
+2K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with…Glove One, LLC20250—
+2K232064Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy…Isikel Manufacturing, LLC20230—