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510(k) Data Aggregation

    K Number
    K033308
    Device Name
    VINYL EXAMINATION GLOVES, POWDERED
    Manufacturer
    TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD.
    Date Cleared
    2003-12-22

    (69 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 worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Vinyl Examination Gloves, Powdered

    AI/ML Overview

    I apologize, but this document is a 510(k) clearance letter from the FDA for "Vinyl Examination Gloves, Powdered." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets them.

    The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with detailed acceptance criteria and performance metrics like those described in your prompt for AI/software devices.

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

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