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510(k) Data Aggregation

    K Number
    K990501
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    1999-04-02

    (44 days)

    Product Code
    LYY
    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

    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

    Powder Free Latex Examination Gloves, with protein labeling claim (50 micrograms or less)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets these criteria. The document is an FDA 510(k) clearance letter for "Powder-Free Natural, Blue, and Green Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less)" from FLEXITECH SDN. BHD.

    It primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also includes an "Indications for Use Statement" for the gloves.

    Therefore, I cannot provide the requested information.

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