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510(k) Data Aggregation

    K Number
    K063046
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2006-11-17

    (44 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K072145
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Nitrile Powder Free Examination Gloves (Green)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Nitrile Powder Free Examination Gloves. It does not contain information about the acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic devices. The details requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance experiments) are typically associated with the evaluation of artificial intelligence or machine learning-based medical devices, not with the clearance of basic medical supplies like examination gloves.

    Therefore, I cannot provide the requested information based on the given document.

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