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510(k) Data Aggregation

    K Number
    K203666
    Device Name
    Vinyl Examination Gloves(Yellow)
    Manufacturer
    Lutai Medical Technology Co.,LTD.
    Date Cleared
    2021-03-12

    (86 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K163168
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lutai Medical Technology Co.,LTD.

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

    The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

    Device Description

    The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

    AI/ML Overview

    This document is a 510(k) summary for Vinyl Examination Gloves (Yellow). It does not describe an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human reader improvement, standalone performance, ground truth, and training set information is not applicable.

    The document assesses the substantial equivalence of the Vinyl Examination Gloves (Yellow) to a predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves (White, Blue, Yellow), K163168).

    The comparison focuses on physical dimensions, performance properties, material, and biocompatibility, demonstrating that the new device meets relevant ASTM and ISO standards for vinyl examination gloves.

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