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510(k) Data Aggregation

    K Number
    K090016
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SUQIAN CLEAN GLOVE CO., LTD.
    Date Cleared
    2009-02-13

    (42 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

    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, Clear (Non-colored)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. This type of information is typically provided in a separate performance study report or clinical trial documentation, which is not present in these pages.

    Therefore, I cannot provide the requested table or details about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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