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FDA 510(k) & PMA Approved Devices — 44 products

Total Devices44
Categories0
Latest FDA decision
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
510(k) K132484 DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILELZA2013-12-13 View
510(k) K083408 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZC2009-07-31 View
510(k) K083410 POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIMLZC2009-07-31 View
510(k) K083409 POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABELLZC2009-07-29 View
510(k) K083305 POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIMLZC2009-06-18 View
510(k) K070619 POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELINGKGO2007-06-27 View
510(k) K040645 DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEILYY2004-04-28 View
510(k) K040503 ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOURKGO2004-03-16 View
510(k) K032942 PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILEKGO2003-12-17 View
510(k) K032647 ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERAKGO2003-11-07 View
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