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510(k) Data Aggregation

    K Number
    K013774
    Device Name
    CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA
    Manufacturer
    SUPERMAX SDN BHD
    Date Cleared
    2002-03-05

    (112 days)

    Product Code
    LZA
    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 medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding "Aurella Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera." This document is a regulatory approval for a medical device (gloves) and does not contain information about software or AI-powered devices, nor does it detail a study with acceptance criteria and performance metrics in the way a clinical validation study for such a device would.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI-powered device from this document. The document primarily focuses on FDA's determination of substantial equivalence for a physical medical product (gloves) to legally marketed predicate devices.

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