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510(k) Data Aggregation

    K Number
    K042952
    Device Name
    VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE
    Manufacturer
    ZIBO HENGCHANG PLASTIC & RUBBER PRODUCTS CO., LTD.
    Date Cleared
    2005-03-10

    (135 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 purpose that A patient cxaminer's hands or finger to prevent contamination between patient and examiner.

    Device Description

    Powder-Free Vinyl Examination Gloves

    AI/ML Overview

    I apologize, but the provided text does not contain information about the acceptance criteria or a study proving a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Vinyl Examination Gloves" (K042952), confirming their substantial equivalence to legally marketed predicate devices.

    It discusses regulatory aspects, compliance requirements, and indications for use of the gloves, but it does not detail performance acceptance criteria or any study results to demonstrate those criteria were met.

    Therefore, I cannot provide the requested information.

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