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510(k) Data Aggregation

    K Number
    K033683
    Device Name
    SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2004-01-08

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

    Device Description

    SMART-FEEL Powder Free Nitrile Examination Gloves (Pink Color)

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter for "Smart-Glove Powder Free Nitrile Examination Gloves Pink Color." This document is a regulatory approval letter from the FDA and does not contain information about acceptance criteria and a study proving device performance as described in the request.

    Therefore, I cannot extract the requested information from this document. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

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