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510(k) Data Aggregation

    K Number
    K063581
    Device Name
    SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
    Manufacturer
    PT MAHAKARYA INTI BUANA
    Date Cleared
    2007-03-15

    (105 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

    Senstouch High Risk Blue Latex Examination Gloves Powdeced, Non-Starile is a disposable device and mad of natural cubber latex for medical purpose that worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of natural rubber latex.

    AI/ML Overview

    The provided text discusses an FDA 510(k) premarket notification for "Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non-Sterile." It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, expert qualifications, or study methodologies. It is a regulatory approval letter, not a performance study report.

    Therefore, I cannot provide the requested information based on the given input.

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