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

    DISPOSABLE POWDERED VINYL EXAM GLOVES

    K Number: K031134 · Decision May 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    795
    Applicant Total
    4
    Review Days
    41

    Basic Information

    Device Name
    DISPOSABLE POWDERED VINYL EXAM GLOVES
    K Number
    K031134
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ELITE INTERNATIONAL, INC.
    Date Received
    April 9, 2003
    Decision Date
    May 20, 2003
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by ELITE INTERNATIONAL, INC.

    K Number Device Name
    K040071 ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
    K032616 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
    K031113 DISPOSABLE POWDER FREE VINYL EXAM GLOVES