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510(k) Data Aggregation

    K Number
    K060771
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
    Manufacturer
    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
    Date Cleared
    2006-05-01

    (40 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K103337
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A 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 Nitrile Patient Examination Gove, White (non-colored) and Blue Colored

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Nitrile Patient Examination Glove." It discusses the regulatory classification and marketing authorization of the device.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of details are typically found in the 510(k) summary or detailed reports, which are not included in the provided text.

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