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510(k) Data Aggregation

    K Number
    K120110
    Device Name
    ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
    Manufacturer
    PROFIT POINT MANUFACTURING SDN BHD
    Date Cleared
    2012-10-04

    (265 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)

    Device Description

    ELEGANT Nitrile Powder Free Examination Gloves

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

    The provided text pertains to the substantial equivalence determination for "Elegant Blue Violet Nitrile Examination Gloves Ambidextrous Powder-Free" (K120110). It states that the device is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." (21 CFR 880.6250).

    Therefore, none of the requested information (1-9) can be extracted from this document, as it is not relevant to the performance evaluation of an AI-powered device.

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