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510(k) Data Aggregation

    K Number
    K062919
    Device Name
    TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2007-03-20

    (173 days)

    Product Code
    LZA
    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 gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

    Device Description

    Textured Powder-Free Nitrile Exam Gloves (Peach)

    AI/ML Overview

    The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific criteria.

    This document is a 510(k) Premarket Notification letter from the FDA, stating that the device (Textured Powder-Free Nitrile Exam Gloves) is substantially equivalent to legally marketed predicate devices. It confirms that the device can be marketed subject to general controls.

    Therefore, I cannot provide the requested information as it is not present in the given text.

    The information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth, and training sets are typically found in the 510(k) submission itself or in a separate study report, not in the FDA's decision letter.

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