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510(k) Data Aggregation

    K Number
    K023560
    Device Name
    ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
    Manufacturer
    SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
    Date Cleared
    2002-12-17

    (55 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 VINYL EXAM GLOVES, POWDERED

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a medical device: "Environ-NP Disposable Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of digital health or AI/ML.

    The document is a regulatory approval letter for a physical medical device (gloves), indicating substantial equivalence to a predicate device. It specifies general controls, regulatory classification, and indications for use.

    Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

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