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510(k) Data Aggregation

    K Number
    K012282
    Device Name
    STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
    Manufacturer
    CYPRESS MEDICAL PRODUCTS, LTD.
    Date Cleared
    2001-08-06

    (17 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 :

    STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE

    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

    Powder Free Sterile Synthetic Vinyl Examination Gloves

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Synthetic Vinyl Patient Examination Gloves" and pertains to regulatory approval, not device performance studies or acceptance criteria. Therefore, I cannot extract the table of acceptance criteria, device performance, or details about any study as this information is not present in the given text.

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