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

    HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES

    K Number: K905086 · Decision Dec 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
    K Number
    K905086
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Hpi, Inc.
    Date Received
    November 14, 1990
    Decision Date
    December 3, 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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    K904878 SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
    K901608 HPI POWDER FREE NON-STERILE EXAMINATION GLOVES