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510(k) Data Aggregation

    K Number
    K113750
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
    Manufacturer
    FULL SYNERGY MEDICAL PRODUCTS INC
    Date Cleared
    2012-03-05

    (75 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

    Device Description

    Disposable Powder Free Vinyl Synthetic Exam Glove, White Color

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Synthetic Exam Glove, White Color. This document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of a medical imaging or AI-powered diagnostic device, which is what your questions are geared towards.

    The document is an approval letter for a medical glove, which falls under general controls and does not require complex performance studies like those for diagnostic devices. Therefore, I cannot extract the information you requested about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the content of this specific regulatory document for a medical glove.

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