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510(k) Data Aggregation

    K Number
    K011961
    Device Name
    POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2001-09-26

    (96 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

    Powder-Free Butadiene Copolymer Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    This product has a pH of 5.5, which is an integral part of this patented product. This is not an antimicrobial/antiseptic glove.

    This device is not intended to be used as a chemical barrier.

    Device Description

    Powder-Free Butadiene Copolymer Examination Gloves, Violet Color

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Shen Wei (USA), Incorporated, concerning their "Powder-Free Butadiene Copolymer Examination Gloves with Aloe, Violet Color." This document is a regulatory approval and does not describe a study that uses AI/ML for medical device performance evaluation.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI, as this document pertains to a traditional medical device (gloves) and their regulatory clearance based on substantial equivalence, not AI/ML performance evaluation.

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