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    K Number
    K020837
    Device Name
    MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2002-12-02

    (263 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K000833
    Why did this record match?
    Device Name :

    MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    disposable device made of natural rubber latex material that may bear a trace amount of glove powder

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "MOTEX Powder-Free Examination Gloves with Protein Labeling Claim (300 Micrograms or Less)." This document is a regulatory approval for a medical device and does not contain any information about a study involving AI, algorithms, or ground truth establishment relevant to the questions asked.

    Therefore, I cannot provide answers to the specific questions because the document describes a physical medical device (gloves) and its regulatory classification, not a software-based device or a study with acceptance criteria and performance metrics typically associated with AI/ML evaluations.

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