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510(k) Data Aggregation

    K Number
    K032746
    Device Name
    SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES
    Manufacturer
    SHANGHAI GIANTMAX PLASTIC PRODUCT CORP.
    Date Cleared
    2003-10-17

    (43 days)

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

    Device Description

    Shanghai Giantmax Plastic Products Powder-Free Clear Vinyl Examination Glove

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a sterile patient examination glove. This document does not contain information about a medical device that uses artificial intelligence (AI) and thus does not include acceptance criteria, study details, or performance metrics in the way your request describes for AI-enhanced devices.

    The document essentially states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general controls and regulations but does not delve into specific performance studies with acceptance criteria as would be expected for a novel AI device.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study information for an AI device. The information provided in the document is for a traditional medical device (gloves) and does not align with the nature of your questions.

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