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

    MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

    K Number: K022305 · Decision Aug 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
    K Number
    K022305
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heyuan Hongli Industries, Inc.
    Date Received
    July 16, 2002
    Decision Date
    August 8, 2002
    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 Heyuan Hongli Industries, Inc.

    K Number Device Name
    K030997 POWDERED VINYL EXAM GLOVES, WHITE
    K011414 POWDERED VINAL EXAM GLOVES
    K011413 POWDER-FREE VINYL EXAM GLOVE, YELLOW
    K011412 POWDER-FREE VINYL EXAM GLOVES