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

    POWDER FREE VINYL EXAMINATION GLOVE

    K Number: K032071 · Decision Oct 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    4
    Review Days
    99

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    Basic Information

    Device Name
    POWDER FREE VINYL EXAMINATION GLOVE
    K Number
    K032071
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Foremost Plastic Industrial Co., Ltd.
    Date Received
    July 3, 2003
    Decision Date
    October 10, 2003
    Product Code
    LYZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Shanghai Foremost Plastic Industrial Co., Ltd.

    K Number Device Name
    K041041 NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    K971415 VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
    K971423 VINYL PATIENT EXAMINATION GLOVE, POWDERED