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510(k) Data Aggregation

    K Number
    K240824
    Device Name
    Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
    Manufacturer
    Ningxia Qiaoen Medical Technology Co., LTD
    Date Cleared
    2024-06-25

    (91 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

    Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves (Non sterile)". This type of medical device is a Class I device and does not involve AI/ML components for diagnosis or treatment. The content of this letter focuses on regulatory compliance for a physical product, not on the performance of a software algorithm.

    Therefore, the requested information about acceptance criteria, study data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc., are not applicable to this document. These details are typically required for AI/ML-driven medical devices that output algorithmic decisions or analyses, not for physical examination gloves.

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