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510(k) Data Aggregation

    K Number
    K040793
    Device Name
    FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES
    Manufacturer
    HL RUBBER PRODUCTS SDN BHD
    Date Cleared
    2004-04-14

    (16 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

    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient

    Device Description

    Powder Free Polymer Coated Latex Examination Glove

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Polymer Coated Latex Examination Gloves". It does not describe acceptance criteria for a study or provide data on device performance. Instead, it indicates that the device has been found substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, etc.) from this document.

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