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510(k) Data Aggregation

    K Number
    K012339
    Device Name
    ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2001-10-16

    (84 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETTERN PATIENT AND EXPMINER.

    Device Description

    Environ-NF DISPOSABLE SYNTHETIC VINYL EXAM GLOVE, POWDER FREE (YELLOW)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device: "Environ-NP Powder Free Synthetic Vinyl Examination Gloves." This document is a regulatory approval and does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the way a performance study for an AI/ML device would.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. The "indications for use" simply describe the intended purpose of the gloves (to prevent contamination between patient and examiner).

    Therefore, I cannot provide the requested information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth types, as these are not present in the provided text.

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