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510(k) Data Aggregation

    K Number
    K021598
    Device Name
    ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
    Date Cleared
    2002-06-10

    (26 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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    K Number
    K020918
    Device Name
    ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
    Date Cleared
    2002-04-19

    (29 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Elastyfree™ Synthetic Powder-Free Surgical Glove
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    K Number
    K984337
    Device Name
    ELASTYLON POWDER-FREE SURGICAL GLOVE
    Date Cleared
    1999-04-09

    (127 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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    K Number
    K971471
    Device Name
    ELASTYREN POWDER-FREE SURGICAL GLOVE
    Date Cleared
    1998-02-09

    (292 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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    K Number
    K970015
    Device Name
    ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
    Date Cleared
    1997-06-24

    (173 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Elastyren Powder-Free Patient Examination Gloves
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