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510(k) Data Aggregation

    K Number
    K991422
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2000-05-03

    (376 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

    Powder-Free Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is a general purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

    Device Description

    Powder-Free Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter (K991422) is a 510(k) clearance letter for "Powder-Free Nitrile Examination Glove (Tested for Use with Chemotherapy Drugs)" and not a study that details acceptance criteria and device performance.

    This document indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. However, it does not contain the specific information required to answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for a medical imaging or AI-driven diagnostic device.

    Therefore, I cannot extract the requested information from the provided text.

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