BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇹 Austria

    Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

    K Number: K250313 · Decision Aug 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    1
    Review Days
    197

    Basic Information

    Device Name
    Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
    K Number
    K250313
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harps Europe Manufacturing GmbH
    Date Received
    February 3, 2025
    Decision Date
    August 19, 2025
    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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