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510(k) Data Aggregation

    K Number
    K980807
    Device Name
    NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)
    Manufacturer
    PT. EKA WIRA ASIA
    Date Cleared
    1998-04-02

    (36 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 wom on the examiner's hand or finger to prevent contamination between patient and examiners.

    Device Description

    Nitrile Patient Examination Gloves - Powder Free Blue and White Color

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Nitrile Examination Gloves - Powderfree" and an "Indication for Use" statement. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

    Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval, not a scientific study report.

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