510(k) Report

Devices descending from K190018

3 later devices reach Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…Ansell Healthcare Products, LLC20230—
+1K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Hartalega NGC Sdn. Bhd.20221—
+2K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.20230—