BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

    K Number: K182948 · Decision Mar 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    26
    Review Days
    150

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    Basic Information

    Device Name
    Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
    K Number
    K182948
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ansell Healthcare Products, LLC
    Date Received
    October 23, 2018
    Decision Date
    March 22, 2019
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by Ansell Healthcare Products, LLC

    K Number Device Name
    K230079 Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
    K213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
    K212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
    K210401 Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
    K190018 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
    K171375 Gammex PI Breach Detect Powder Free Surgical Glove
    K171737 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
    K171172 Skyn Original Polyisoprene Lubricated Male Condom - Flavored
    K163107 Lifestyles Zero Lubricated Latex Male Condom
    Search all 26 clearances from Ansell Healthcare Products, LLC →