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510(k) Data Aggregation

    K Number
    K990415
    Device Name
    LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-03-29

    (47 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

    Laglove™ Brand Nitrile Examination Glove (Powdered) is a 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 Nitrile Examination Gloves (Powdered)

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for Laglove™ Brand Nitrile Examination Gloves (Powdered). It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

    The letter does not contain details about:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for test sets or data provenance.
    • Number of experts or their qualifications for establishing ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance studies.
    • Types of ground truth used.
    • Sample size for training sets.
    • How ground truth for training sets was established.

    The document primarily focuses on the regulatory clearance for the gloves, stating their intended use and classification.

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