510(k) Report

Devices descending from K082957

6 later devices reach Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101822Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy…Sgmp Co., Ltd.20105—
+2K111248Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd20114—
+3K211810Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy…Pt. Shamrock Manufacturing Corpora20221—
+3K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and…Medline Industries, Inc.20201—
+4K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with…Glove One, LLC20250—
+4K232064Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy…Isikel Manufacturing, LLC20230—