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510(k) Data Aggregation

    K Number
    K013828
    Device Name
    GLOVCO EBONY
    Manufacturer
    GLOVCO (M) SDN. BHD.
    Date Cleared
    2002-08-13

    (267 days)

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

    GLOVCO EBONY

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

    A patient examination glove that is worn by the healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

    Device Description

    Black Coloured Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 micrograms or less)

    AI/ML Overview

    This document is a 510(k) premarket notification for latex examination gloves. It does not contain information about a study proving a device meets acceptance criteria in the context of an AI/ML medical device. The document is concerned with the regulatory clearance of a medical glove. Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this input.

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