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510(k) Data Aggregation

    K Number
    K110314
    Device Name
    STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
    Manufacturer
    TRUE GLOVE FACTORY
    Date Cleared
    2011-05-10

    (97 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 Vinyl examination glove, Powder Free, Clear (Non-Colored) is a non-sterile 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

    Stretch Vinyl Examination Glove, Powder Free (Yellow/White/Clear (non-colored)

    AI/ML Overview

    The provided text is a letter from the FDA regarding the 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.

    Therefore, I cannot extract the requested information from the provided text.

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