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510(k) Data Aggregation

    K Number
    K080165
    Device Name
    SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
    Manufacturer
    PLATINUM GLOVE INDUSTRIES SDN.BHD.
    Date Cleared
    2008-05-14

    (112 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

    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Smart Savers, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray color

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Platinum Glove Industries Sdn Bhd for their "Smart Savers, Powder Free Nitrile Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    The document does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth, or any other details related to AI/algorithm performance studies. The context of the request is entirely focused on what would be found in a study for an AI-powered medical device, which is not applicable here.

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

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