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510(k) Data Aggregation

    K Number
    K063524
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
    Manufacturer
    HL RUBBER INDUSTRIES SDN BHD
    Date Cleared
    2007-01-23

    (62 days)

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

    POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)

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

    A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.

    Device Description

    Powder - Free Nitrile White and Blue Examination Gloves

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter for "Powder-Free Nitrile White and Blue Examination Glove" and an "Indication for Use" statement from the manufacturer.

    This document describes the regulatory clearance of a medical device (examination gloves) based on substantial equivalence to a legally marketed predicate device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML powered device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

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