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510(k) Data Aggregation

    K Number
    K974777

    Validate with FDA (Live)

    Device Name
    VINYL EXAMINATION GLOVES POWDER FREE
    Manufacturer
    SUN FLOWER GLOVES CO., LTD.
    Date Cleared
    1998-01-30

    (39 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient 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.

    Device Description

    Patient examination glove VINYL - POWDER FREE

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves Powder Free." It is not a study report for a medical device that uses acceptance criteria based on performance metrics that would be evaluated by experts or AI.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these concepts are not applicable to the content of this regulatory approval.

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