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510(k) Data Aggregation

    K Number
    K063627
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2007-03-20

    (104 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 a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

    Device Description

    Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy (Blue)

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy (Blue)". It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.

    Therefore, I cannot answer the question based on the provided text. The document is about medical gloves, not an AI/ML device, and thus doesn't discuss performance metrics like sensitivity, specificity, or typical study designs for AI systems.

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