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510(k) Data Aggregation

    K Number
    K210460
    Device Name
    NitriTec Vinyl Glove Powder Free Blue
    Manufacturer
    Zhonghong Pulin Medical Products Co.,Ltd.
    Date Cleared
    2021-05-17

    (90 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NitriTec Vinyl Glove Powder Free Blue

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

    Device Description

    NitriTec Vinyl Glove Powder Free Blue

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter (K210460) for the "NitriTec Vinyl Glove Powder Free Blue" does not contain any information about acceptance criteria or a study proving device performance for artificial intelligence (AI) or machine learning (ML) models.

    This document is a 510(k) premarket notification clearance letter for a Class I medical device (Non-Powdered Patient Examination Glove). Such devices are typically cleared based on substantial equivalence to a predicate device and do not require extensive performance studies as would be necessary for a novel AI/ML diagnostic or therapeutic device.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance with the specified details (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance) using the provided text. The information simply isn't there.

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