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510(k) Data Aggregation

    K Number
    K020865
    Device Name
    ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
    Manufacturer
    APL PRODUCTS SDN. BHD.
    Date Cleared
    2002-05-08

    (51 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 a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    ONLINE POWDER FREE, LATEX EXAMINATION GLOVES

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to APL Products Sdn. Bhd. for their "Online Powder Free, Latex Examination Gloves". It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

    The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a premarket approval application (PMA). Substantial equivalence is generally based on demonstrating the new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics and performance data to that of the predicate, but the specific acceptance criteria and detailed study results are not provided in this document.

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

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