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510(k) Data Aggregation

    K Number
    K211699
    Device Name
    Nitrile Exam Gloves, Powder Free, Blue
    Manufacturer
    Hengchang (Dongying) Medical Technology Co.,Ltd.
    Date Cleared
    2021-08-20

    (78 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

    The Nitrile Exam Gloves, Powder Free, Blue are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

    Device Description

    Nitrile Exam Gloves, Powder Free, Blue

    AI/ML Overview

    This document is a 510(k) clearance letter for Nitrile Exam Gloves. It confirms that the device is substantially equivalent to a legally marketed predicate. However, it does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

    Specifically, the letter is an administrative document from the FDA clearing the device for market. It focuses on regulatory compliance (e.g., registration, listing, good manufacturing practices, labeling) and the substantial equivalence determination, rather than performance studies with acceptance criteria.

    Therefore, I cannot provide the requested information based on the provided text.

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