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510(k) Data Aggregation

    K Number
    K971471
    Device Name
    ELASTYREN POWDER-FREE SURGICAL GLOVE
    Manufacturer
    ECI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-02-09

    (292 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 surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    Elastyren Powder-Free Surgical Glove

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the Elastyren Powder-Free Surgical Glove. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter, not a device performance study report.

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