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

    SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES

    K Number: K022639 · Decision Sep 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    2
    Review Days
    39

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    Basic Information

    Device Name
    SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES
    K Number
    K022639
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shijiazhuang Holy Plastics Co., Ltd.
    Date Received
    August 8, 2002
    Decision Date
    September 16, 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 Shijiazhuang Holy Plastics Co., Ltd.

    K Number Device Name
    K022702 POWDERED SYNTHETIC VINYL EXAM GLOVES