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510(k) Data Aggregation

    K Number
    K101760
    Device Name
    ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
    Manufacturer
    PROFIT POINT MANUFACTURING SDN BHD
    Date Cleared
    2010-10-06

    (105 days)

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

    ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES

    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

    Model 1: White Nitrile, Powder Free Examination Gloves
    Model 2: Blue Nitrile, Powder Free Examination Gloves
    Model 3: Pink Nitrile, Powder Free Examination Gloves

    AI/ML Overview

    The input document is a letter from the FDA regarding a 510(k) premarket notification for "Elegant Powder Free Nitrile Examination Gloves". It primarily addresses the substantial equivalence determination for the device. The document does not contain any information about acceptance criteria for a device's performance, nor does it describe any study related to device performance, sample sizes, ground truth establishment, or expert adjudication that would be relevant to the questions posed.

    Therefore, I cannot provide the requested information based on the provided text. The questions are designed for a document describing a clinical study or performance evaluation of a medical device, which this document is not.

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