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510(k) Data Aggregation

    K Number
    K162175
    Device Name
    Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
    Manufacturer
    Viet Glove Corporation
    Date Cleared
    2016-11-21

    (110 days)

    Product Code
    LYY
    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

    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

    Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less

    AI/ML Overview

    I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less." It primarily discusses the regulatory approval of the glove and its classification.

    This document does not contain any information about:

    • Acceptance criteria or device performance data for an AI/ML medical device.
    • Study details such as sample sizes, data provenance, ground truth establishment, expert qualifications, or MRMC studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.

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