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

    CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE

    K Number: K974371 · Decision Apr 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    152

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    Basic Information

    Device Name
    CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
    K Number
    K974371
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clk Intl., Inc.
    Date Received
    November 20, 1997
    Decision Date
    April 21, 1998
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Clk Intl., Inc.

    K Number Device Name
    K974301 CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER