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510(k) Data Aggregation

    K Number
    K980785
    Device Name
    STERILE, POWDERFREE LATEX EXAMINATION GLOVE
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-06-10

    (100 days)

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

    STERILE, POWDERFREE LATEX EXAMINATION GLOVE

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

    An examination glove is a disposable device intended for medical purposes "An examinon Eroro is a carperation or finger to prevent contamination between patient and examiner."

    Device Description

    Regent™ Safetex™ Sterile Latex Medical Examination Glove, Powder-Free,Less than 50mcg/gram Total Protein

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device: Regent™ Safetex™ Sterile Latex Medical Examination Glove, Powder-Free, Less than 50mcg/gram Total Protein.

    The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The document is primarily an FDA letter clearing the device for market based on substantial equivalence to a predicate device. It defines the product and its intended use, but it does not detail any performance studies, test results, or the methodologies used to establish such results.

    Therefore, I cannot provide the requested information based on the provided text.

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