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510(k) Data Aggregation

    K Number
    K213144
    Device Name
    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-12-22

    (86 days)

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

    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

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

    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors are disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

    AI/ML Overview

    This document is a 510(k) clearance letter for "Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors" from Shen Wei USA Inc. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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

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