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510(k) Data Aggregation

    K Number
    K092411
    Device Name
    PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2009-10-21

    (75 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K101436
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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 single use only.

    Device Description

    Yellow, Red, Green, Black, Blue with Pearlescent™ Pigment, Powder-Free Nitrile Examination Gloves with Aloe Vera

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. Therefore, I cannot generate the requested table and study description.

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