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510(k) Data Aggregation

    K Number
    K010097
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2001-03-30

    (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
    Device Description
    AI/ML Overview
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    K Number
    K993876
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2000-02-07

    (84 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K162312
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder-Free Nitrile Exam Glove with Aloe Vera is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

    Device Description

    Powder-Free Nitrile Exam Gloves with Trade Name: Aloe Vera, Green Color

    AI/ML Overview

    This document is a 510(k) clearance letter for Powder-Free Nitrile Examination Gloves. It does not contain information on acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information.

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