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510(k) Data Aggregation

    K Number
    K984337
    Device Name
    ELASTYLON POWDER-FREE SURGICAL GLOVE
    Manufacturer
    ECI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-04-09

    (127 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A surgical glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    Elastylon ® Powder-Free Surgical Glove

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter confirms substantial equivalence of the "Elastylon Powder-Free Surgical Glove" to a legally marketed predicate device, enabling its market entry. Therefore, I cannot extract the requested information from this document.

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