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510(k) Data Aggregation

    K Number
    K061078
    Device Name
    BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
    Manufacturer
    BRIGHT ELEMENT SDN BHD
    Date Cleared
    2006-05-19

    (32 days)

    Product Code
    LYY
    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

    A patient examination Latex Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Latex Powder Free Examination Glove

    AI/ML Overview

    This document is a 510(k) clearance letter for a "Latex Powder Free Examination Glove." It does NOT contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for this type of medical device (a physical glove) to be marketed, but there are no performance metrics or clinical study details as would be expected for a SaMD.

    Therefore, I cannot provide the requested information for an AI/SaMD according to the provided text. The document pertains to a physical medical device (examination glove) and its regulatory clearance based on substantial equivalence, not a software device with performance criteria.

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