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510(k) Data Aggregation

    K Number
    K981600
    Device Name
    LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
    Manufacturer
    YOUNG INNOVATIONS LLC DBA PLAK SMACKER
    Date Cleared
    1998-11-02

    (182 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.

    Device Description

    Latex Patient Examination Gloves BUBBLE GUM FLAVOR PRE-POWDERED

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves Bubble Gum Trade Name: Flavored Pre-Powdered." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain any information about acceptance criteria, device performance, a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The letter is a regulatory clearance and not a study report or technical specification document. Therefore, I cannot extract the requested information from the provided text.

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