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510(k) Data Aggregation

    K Number
    K213029
    Date Cleared
    2021-12-14

    (84 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

    Device Description

    The proposed device, Nitrile Examination Gloves (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

    The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.

    The proposed device is provided non-sterile. The proposed device is made of Nitrile.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study results for "Nitrile Examination Gloves (Powder free, Blue)". This is a physical medical device, not a software-driven AI device. Therefore, the specific questions regarding AI-related performance metrics (like sample size for test set/training set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to this document.

    However, I can extract the acceptance criteria and reported device performance from the provided tables.

    Acceptance Criteria and Reported Device Performance

    Test MethodPurposeAcceptance CriteriaReported Device PerformanceComments
    Physical Performance (ASTM D6319, D412, D573)
    Freedom from Holes (ASTM D5151)Testing for Freedom from holesAQL 2.5No water leakage is inspected from 200 samplesMeets acceptance criteria.
    Residual Powder (ASTM D6124)Determine the powder residue for powder free gloves
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