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    K Number
    K032781
    Device Name
    BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD.
    Date Cleared
    2003-11-13

    (66 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K000071
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder free vinyl 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

    powder free vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves," not an AI-powered medical device study. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

    However, I can extract the relevant information about the device's performance based on the provided document:

    Acceptance Criteria and Device Performance

    CharacteristicsStandardReported Device Performance
    DimensionASTM standard D 5250-00e4Meets
    Physical PropertiesASTM standard D 5250-00e4Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-00e4
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