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

    GLOVE, SUPERFLEX MOLDED

    K Number: K781852 · Decision Nov 15, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    GLOVE, SUPERFLEX MOLDED
    K Number
    K781852
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Pinnacle Distributors, Inc.
    Date Received
    November 6, 1978
    Decision Date
    November 15, 1978
    Product Code
    KPY
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPY Shield, Protective, Personnel

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