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510(k) Data Aggregation

    K Number
    K990577
    Device Name
    TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
    Manufacturer
    TA CHIA RUBBER IND. CORP.
    Date Cleared
    1999-05-04

    (70 days)

    Product Code
    LZA
    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

    Powder Free Non-Sterile Nitrile Examination Gloves

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for patient examination gloves and focuses on regulatory approval rather than a detailed study description with acceptance criteria and performance metrics. Therefore, I cannot extract the specific details about acceptance criteria, study design, expert qualifications, or ground truth establishment that you are looking for.

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