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

    L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)

    K Number: K896076 · Decision Jan 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    32
    Review Days
    77

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    Basic Information

    Device Name
    L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
    K Number
    K896076
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Advance Medical Designs, Inc.
    Date Received
    October 19, 1989
    Decision Date
    January 4, 1990
    Product Code
    LZC
    Advisory Committee
    General Hospital
    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
    LZC Medical Glove, Specialty

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