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510(k) Data Aggregation

    K Number
    K994036
    Device Name
    PRE-POWDERED VINYL EXAM GLOVE, NON STERILE
    Manufacturer
    SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    1999-12-20

    (21 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    PRE-POWDERED NON-STERILE. VINYL EXAMINATION GLOVES

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA to Shanqhai Champion Plastic Products Co., Ltd. for pre-powdered vinyl examination gloves. It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such studies and criteria are typically found in the 510(k) submission itself, of which this letter is only the clearance response.

    Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results against specific acceptance criteria.

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