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510(k) Data Aggregation

    K Number
    K971949
    Device Name
    POWDER-FREE PATIENT EXAMINATION GLOVES
    Manufacturer
    TEKMEDIC (M) SDN BHD
    Date Cleared
    1997-07-28

    (61 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 medical glove is worn on the hand. of health care and similar personnel to prevent contamination between healthcare personnel and the patient.

    Device Description

    Tekmedic Powder-Free LATEX Examination Gloves

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving device performance as typically expected for complex medical devices like AI algorithms or diagnostic tools. The content focuses on regulatory compliance for a Class I medical device (Powder-Free Latex Patient Examination Gloves).

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or expert qualifications because it is not present in the provided text.

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