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FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories3
Latest FDA decision2024-03-28
TypeNumberDevice NameCodeDateActions
510(k) K232079 Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylKGO2024-03-28 View
510(k) K232538 DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYLLZA2023-11-17 View
510(k) K230578 Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylKGO2023-08-31 View
510(k) K222058 Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantKGO2022-10-22 View
510(k) K211601 Powder Free Latex Examination Glove, Non-SterileLYY2022-08-22 View
510(k) K210330 Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantLZA2022-03-04 View
510(k) K203030 POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGSKGO2021-06-11 View
510(k) K192635 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)LZA2020-01-17 View
510(k) K161823 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsKGO2017-01-23 View
510(k) K161422 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2016-10-20 View
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