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510(k) Data Aggregation

    K Number
    K031854
    Device Name
    VINYL EXAM GLOVES, POWDER-FREE, YELLOW
    Manufacturer
    SHANGHAI JIAWANG INDUSTRIAL CO. LTD.
    Date Cleared
    2003-07-25

    (39 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

    VINYL EXAM GLOVES, POWDER-FREE, YELLOW

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria.

    The document is a US FDA 510(k) clearance letter for "Vinyl Exam Gloves, Powder Free, Yellow." It states that the device is substantially equivalent to legally marketed predicate devices. This type of clearance relies on demonstrating substantial equivalence to pre-existing devices, rather than presenting new performance study data against specific acceptance criteria.

    Therefore, I cannot provide the requested information based on the given text.

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