510(k) Report

Devices descending from K112012

2 later devices reach Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232319Black Pearl Nitrile Examination GloveUg Global Resources Sdn. Bhd.20240—
+1K162510Non-Sterile, Powder-Free, Nitrile Examination Gloves, BlueUg Global Resources Sdn. Bhd.20170—