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510(k) Data Aggregation

    K Number
    K220561
    Device Name
    Disposable Medical Nitrile Examination Gloves
    Manufacturer
    Nanjing universal medical equipment Co., Ltd
    Date Cleared
    2022-04-14

    (45 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

    This device is 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

    This document is a 510(k) clearance letter from the FDA for "Disposable Medical Nitrile Examination Gloves." It does not contain information about acceptance criteria or a study proving that an AI-powered device meets acceptance criteria. The document is strictly for a medical glove, which is a physical medical device, not a software or AI-driven diagnostic tool. Therefore, I cannot extract the requested information from this document.

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