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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?
    Applicant Name (Manufacturer) :

    PROFIT POINT MANUFACTURING SDN BHD

    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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    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?
    Applicant Name (Manufacturer) :

    PROFIT POINT MANUFACTURING SDN BHD

    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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