510(k) Report

Devices descending from K972615

4 later devices reach Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083409Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy…Wrp Asia Pacific Sdn. Bhd.20093—
+2K123819Multiple NameTop Calibre Sdn Bhd20130—
+2K121926Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with…Northstar Healthcare Holdings20121—
+3K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.20220—