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510(k) Data Aggregation

    K Number
    K091422
    Device Name
    NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
    Manufacturer
    NOVAPRO CO., LTD.
    Date Cleared
    2009-07-30

    (78 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 Stretch Vinyl examination glove(Yellow/white) 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

    Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Novapro Company, Limited regarding their Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/device study.

    The letter is an approval for a medical device (examination gloves) based on a determination of substantial equivalence to legally marketed predicate devices, not on the results of a specific performance study in the way one would describe for an AI/diagnostic device.

    Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided input.

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