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

    POWDER FREE VINYL EXAMINATION GLOVE

    K Number: K964545 · Decision Dec 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    8
    Review Days
    47

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    Basic Information

    Device Name
    POWDER FREE VINYL EXAMINATION GLOVE
    K Number
    K964545
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shanghai Poseidon Plastic Products Co., Ltd.
    Date Received
    November 13, 1996
    Decision Date
    December 30, 1996
    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 Shanghai Poseidon Plastic Products Co., Ltd.

    K Number Device Name
    K001836 NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
    K001837 NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
    K001549 MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
    K001128 NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
    K992979 SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
    K982885 PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
    K954381 SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES