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510(k) Data Aggregation

    K Number
    K971316
    Device Name
    POLY (VINYL) EXAM GLOVE, POWDERED
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1997-08-27

    (140 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 :

    POLY (VINYL) EXAM GLOVE, POWDERED

    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 on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDERED

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Patient Examination Glove. This document primarily addresses the substantial equivalence of the device to legally marketed predicate devices and outlines general regulatory compliance.

    It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or any analytical or clinical performance data typically associated with a "device" in the context of AI tools or diagnostics.

    Therefore, I cannot extract the requested information as it is not present in the provided document. The sections you asked for, such as sample size, ground truth establishment, expert qualifications, and AI-related performance metrics, are entirely absent.

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