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510(k) Data Aggregation

    K Number
    K981878
    Device Name
    POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-08-11

    (75 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 Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder-Free Nitrile Examination Gloves (Polymer Coated)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Powder-Free Nitrile Examination Gloves (Polymer Coated)". It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

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

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