510(k) Report

Devices descending from K111139

5 later devices reach Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC20193—
+1K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera…Medline Industries, Inc.20150—
+2K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…Ansell Healthcare Products, LLC20230—
+2K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Hartalega NGC Sdn. Bhd.20221—
+3K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.20230—