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510(k) Data Aggregation

    K Number
    K982218
    Device Name
    NITRILE POWDER-FREE UNISEAL GLOVES
    Manufacturer
    AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
    Date Cleared
    1998-11-30

    (159 days)

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

    NITRILE POWDER-FREE UNISEAL GLOVES

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

    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    UNISEAL POWDER-FREE NITRILE EXAMINATION GLOVES

    AI/ML Overview

    I'm sorry, but this document contains a letter from the FDA regarding the substantial equivalence of Uniseal Nitrile Powder-Free Examination Gloves to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets those criteria, as requested in your prompt. The document is a regulatory notification, not a performance study report.

    Therefore, I cannot extract the requested information from this document.

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