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510(k) Data Aggregation

    K Number
    K041848
    Device Name
    POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
    Manufacturer
    PT. SMART GLOVE INDONESIA
    Date Cleared
    2004-08-20

    (43 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K161496
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is a 510(k) premarket notification letter from the FDA to PT. Smart Glove Indonesia regarding their Polymer Coated Powder Free Nitrile Examination Gloves.

    This document indicates that the FDA has reviewed the company's application and has determined the gloves are substantially equivalent to legally marketed predicate devices. This means the device can proceed to market, subject to general controls.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this type of information is not present in the provided document.

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