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510(k) Data Aggregation

    K Number
    K093759
    Device Name
    MULTIPLE NAME MODEL MULTIPLE
    Manufacturer
    GX CORPORATION SDN BHD (PLANT 1)
    Date Cleared
    2010-02-19

    (74 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 :

    MULTIPLE NAME MODEL MULTIPLE

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

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

    Device Description

    Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Blue

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth for a medical device or AI system.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided document. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a description of a performance study.

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