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510(k) Data Aggregation

    K Number
    K990427
    Device Name
    ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
    Manufacturer
    ALLIANCE RUBBER PRODUCTS SDN. BHD.
    Date Cleared
    1999-04-23

    (71 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 gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for "Arsoft Nitrile Examination Gloves, Non-Sterile Powder-Free." This document does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it relates to an AI/ML-enabled medical device.

    The letter is a regulatory approval for a physical medical device (gloves) based on substantial equivalence to a predicate device, not on performance criteria measured through a clinical or technical study in the context of AI/ML.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.

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