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510(k) Data Aggregation

    K Number
    K973801
    Device Name
    HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1997-11-21

    (46 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 examiner.

    Device Description

    Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)". It indicates that the device has been determined to be substantially equivalent to previously marketed devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the input text. The provided text is a regulatory notification, not a technical report detailing device performance studies.

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