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

    NITRILE EXAM GLOVE, POWDER-FREE, BLUE

    K Number: K980802 · Decision Mar 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    4
    Review Days
    23

    Basic Information

    Device Name
    NITRILE EXAM GLOVE, POWDER-FREE, BLUE
    K Number
    K980802
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TUCKER & ASSOCIATES
    Date Received
    March 2, 1998
    Decision Date
    March 25, 1998
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by TUCKER & ASSOCIATES

    K Number Device Name
    K022256 SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
    K980827 LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
    K970835 FACE MASK, SURGICAL MASK, NON-STERILE