510(k) Report

Devices descending from K083409

3 later devices reach Powder Free Blue Latex Patient Examination Gloves, Tested for Use with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123819Multiple NameTop Calibre Sdn Bhd20130—
+1K121926Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with…Northstar Healthcare Holdings20121—
+2K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.20220—