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510(k) Data Aggregation

    K Number
    K990285
    Device Name
    LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-02-18

    (20 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

    Laglove™ Brand Latex Examination Glove (1) disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

    Device Description

    Laglove™ Brand Latex Powdered Examination Gloves with 80 Micrograms or Less of Total Water Extractable Protein Per Gram

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) letter for "Laglove™ Brand Latex Powdered Examination Gloves" does not contain any information about acceptance criteria or a study proving the device meets said criteria.

    This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device already on the market. It confirms the device's regulatory class and provides information about general controls. It does not detail specific performance metrics, clinical studies, or the methodologies used to assess those metrics.

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

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