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510(k) Data Aggregation

    K Number
    K211455
    Device Name
    Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-07-28

    (79 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors."

    This document does not contain any information about an AI/ML medical device, its acceptance criteria, or a study proving its performance. It specifically relates to a Class I medical device (non-powdered patient examination glove) and focuses on regulatory aspects like substantial equivalence, general controls, and compliance.

    Therefore, I cannot provide the requested information about acceptance criteria and a study to prove a device meets them, as the provided input does not describe such a device or study.

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