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510(k) Data Aggregation

    K Number
    K972624
    Device Name
    POLY (VINYL) EXAM GLOVE, POWDER-FREE
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1997-11-06

    (115 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, POWDER-FREE

    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), POWDER FREE

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Poly (Vinyl) Examination Glove, Powder-Free, and primarily discusses regulatory approval. It does not contain information about specific technical acceptance criteria, a study proving performance, sample sizes for testing or training, expert qualifications, or ground truth methodologies for an AI/device performance study. Therefore, I cannot extract the requested information from the provided text.

    The closest information available is the "Indications For Use" which describes the intended purpose of the glove: "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." This states what the device is for, but not directly measurable performance criteria from a study.

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