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510(k) Data Aggregation

    K Number
    K061756
    Device Name
    TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2007-04-19

    (302 days)

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

    TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP

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

    A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250) This device is not intended to be used as a chemical barrier.

    Device Description

    Textured Powder Free Nitrile Examination Gloves (Blue color) with SAP (Super Absorbent Polymer), Textured Powder Free Latex Examination (Natural color) with SAP (Super Absorbent Polymer)

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for medical examination gloves and does not contain information about acceptance criteria, study details, or device performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the given document.

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