BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    ELASTYREN(R) PATIENT EXAMINATION GLOVES

    K Number: K946291 · Decision Feb 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    9
    Review Days
    49

    Basic Information

    Device Name
    ELASTYREN(R) PATIENT EXAMINATION GLOVES
    K Number
    K946291
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ECI MEDICAL TECHNOLOGIES, INC.
    Date Received
    December 27, 1994
    Decision Date
    February 14, 1995
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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    Other Clearances by ECI MEDICAL TECHNOLOGIES, INC.

    K Number Device Name
    K021598 ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
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    K984337 ELASTYLON POWDER-FREE SURGICAL GLOVE
    K971471 ELASTYREN POWDER-FREE SURGICAL GLOVE
    K970015 ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
    K954535 ELASTYREN HYPOALLERGENIC SURGICAL GLOVES
    K954533 ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES
    K945833 ELASTYREN(R) SURGICAL GLOVES