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510(k) Data Aggregation

    K Number
    K213912
    Device Name
    Disposable Medical Nitrile Examination Gloves
    Manufacturer
    Jiangsu Maolin Medical Technology Co., Ltd
    Date Cleared
    2022-02-19

    (66 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 are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Disposable Medical Nitrile Examination Gloves

    AI/ML Overview

    The provided FDA 510(k) clearance letter (K213912) is for "Disposable Medical Nitrile Examination Gloves." This document does not describe a software device or an AI/ML algorithm. Instead, it concerns a physical medical device.

    Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details cannot be extracted from this document as it pertains to a different type of medical device altogether.

    The document confirms the substantial equivalence of the gloves to a predicate device and outlines general regulatory obligations for the manufacturer. It does not contain any performance metrics or study designs related to AI/ML or diagnostic accuracy.

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