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510(k) Data Aggregation

    K Number
    K990695
    Device Name
    OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
    Manufacturer
    OMNIGRACE (THAILAND) LTD.
    Date Cleared
    1999-05-04

    (62 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

    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

    Device Description

    Omni Touch Nitrile Examination Glove, Powdered, White

    AI/ML Overview

    I am sorry, but because the document is a scanned image, I cannot provide details on the study and acceptance criteria. My current capabilities do not allow me to extract and process information from documents in image format.

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