510(k) Report

Devices descending from K101822

5 later devices reach Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111248Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd20114—
+2K211810Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy…Pt. Shamrock Manufacturing Corpora20221—
+2K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and…Medline Industries, Inc.20201—
+3K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with…Glove One, LLC20250—
+3K232064Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy…Isikel Manufacturing, LLC20230—