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510(k) Data Aggregation

    K Number
    K981942

    Validate with FDA (Live)

    Device Name
    LATEX POWDER FREE EXAMINATION GLOVES
    Manufacturer
    MAIKA RUBBER PRODUCTS SDN BHD
    Date Cleared
    1998-12-14

    (195 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A Latex Powder Free examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient

    Device Description

    Latex Powder-Free Examination Gloves

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Latex Powder-Free Examination Gloves." It is not a study demonstrating the performance of an AI-powered medical device. Therefore, it does not contain the information requested in the prompt.

    The document discusses:

    • The FDA's review of a premarket notification (510(k)) for examination gloves.
    • The determination of substantial equivalence to legally marketed predicate devices.
    • The classification of the device (Class I) and applicable regulations.
    • The intended use of the gloves ("worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient").

    There is no mention of acceptance criteria for an AI device, study results, sample sizes, expert ground truth, MRMC studies, or training sets for AI.

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