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510(k) Data Aggregation

    K Number
    K980318
    Device Name
    POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    1998-03-11

    (43 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

    The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Powder Free Latex Examination Gloves, with Protein Labeling Claim - BLUE Total water extractable Protein claim.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Latex Examination Gloves (Blue)". This document does not contain any information regarding the acceptance criteria, device performance, study details, or ground truth establishment for a medical device that uses AI or machine learning.

    The letter is a regulatory approval for a physical medical device (gloves) and focuses on substantial equivalence to predicate devices, general controls, and compliance with manufacturing practices. Therefore, I cannot extract the requested information from this document.

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