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510(k) Data Aggregation

    K Number
    K993127
    Device Name
    MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
    Manufacturer
    GLOVESWORLD INDUSTRIES SDN. BHD.
    Date Cleared
    1999-12-02

    (73 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

    A Patient Examination Glove is a disposable device intended for medical purposes that is to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Nitrile Patient Examination Gloves (Powder Free)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Multi-Comfort Nitrile Examination Gloves, (Powder Free)". This document declares substantial equivalence to a predicate device and permits marketing. It does not contain any information regarding clinical studies, acceptance criteria, or performance data for the device itself.

    Therefore, I cannot provide the requested information. The letter only confirms regulatory approval based on substantial equivalence, not on specific performance data from studies described within this document.

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