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510(k) Data Aggregation

    K Number
    K092034
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
    Manufacturer
    PT. SMART GLOVE INDONESIA
    Date Cleared
    2009-10-19

    (105 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

    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Powder Free Nitrile Examination Gloves, Black

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Black." This document does not contain information about acceptance criteria or a study proving a device meets those criteria, as it pertains to AI/medical imaging devices.

    Instead, this document is a regulatory letter, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices. It outlines the regulatory classification, product code, and relevant FDA regulations for the device (patient examination gloves).

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

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