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510(k) Data Aggregation

    K Number
    K023343
    Device Name
    ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
    Manufacturer
    SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
    Date Cleared
    2002-10-28

    (21 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 PATIENT EXAMINATION GLOVE 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

    ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED

    AI/ML Overview

    I am sorry, but the provided text only contains information about the FDA's clearance of "ENVIRON-NP Disposable Synthetic Vinyl Examination Gloves, Powdered" and does not include any details regarding acceptance criteria for a study, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

    The document is a 510(k) clearance letter, which means the device was found substantially equivalent to a legally marketed predicate device, rather than undergoing a new clinical study to establish acceptance criteria based on performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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