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510(k) Data Aggregation

    K Number
    K111012
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
    Manufacturer
    TRUE GLOVE FACTORY
    Date Cleared
    2011-07-06

    (85 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 Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent device in between patient and examiner.

    Device Description

    Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)". This document primarily deals with regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

    It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.

    Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria and performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training). The document is a regulatory approval letter, not a scientific study report.

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