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510(k) Data Aggregation

    K Number
    K034060
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)
    Manufacturer
    HONG HUANG TANG INDUSTRIAL CO., LTD.
    Date Cleared
    2004-02-06

    (37 days)

    Product Code
    LYZ
    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 gloves 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

    Powder Free Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Synthetic Examination Gloves White Color (Sensi-Pro)". It establishes the device's substantial equivalence to previously marketed devices and outlines regulatory compliance.

    The document does not describe:

    • Any acceptance criteria for device performance.
    • Any study proving acceptance criteria.
    • Sample sizes for test sets or training sets.
    • Data provenance, expert qualifications, or ground truth establishment.
    • Any multi-reader multi-case studies or standalone algorithm performance.

    Therefore, I cannot fulfill your request based on the provided input.

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