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

    RADIATION PROTECTION GLOVES

    K Number: K900972 · Decision May 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    60

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    Basic Information

    Device Name
    RADIATION PROTECTION GLOVES
    K Number
    K900972
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Infab Corp.
    Date Received
    March 2, 1990
    Decision Date
    May 1, 1990
    Product Code
    IWP
    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
    IWP Radiographic Protective Glove

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    Other Clearances by Infab Corp.

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    K900970 RADIATION PROTECTION GLASSES
    K901014 RADIOGRAPHIC INTENSIFYING SCREEN
    K901012 RADIOGRAPHIC GRID
    K901013 RADIOGRAPHIC FILM CASSETTE
    K896289 RADIATION PROTECTION APRON