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510(k) Data Aggregation

    K Number
    K030207
    Device Name
    NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2003-05-02

    (101 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735

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

    Nitrile Powder-free Examination Glove, ProBlue is a disposable device made of synthetic materials intended for medical purposes that are worn on the examiner's hand or finger(s) to prevent contamination of potentially infectious materials between patient and examiner.

    Device Description

    Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735." This document outlines the FDA's determination of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for an AI/ML product.

    The letter is for a physical medical glove and discusses regulatory compliance for manufacturing and marketing, not the performance metrics of a software or AI device. Therefore, I cannot generate the requested table and study information based on this document.

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