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510(k) Data Aggregation

    K Number
    K022873
    Device Name
    POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)
    Manufacturer
    INTERNATIONAL BIOMEDICAL, INC.
    Date Cleared
    2003-03-21

    (204 days)

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

    INTERNATIONAL BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free surgeon's glove is a device made of synthetic latex 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. The radiation attenuating surgical glove is intended to be used during medical procedures where hands are necessarily exposed to radiation in order to offer some degree of protection to the hand from radiation. This includes surgical procedures that require the use of fluoroscopy or radiography.
    Device Description
    The Powder-Free Radiation Attenuating Surgical Gloves are formulated using neoprene, synthetic latex. The gloves are supplied powder-free and sterile.
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    K Number
    K022876
    Device Name
    MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
    Manufacturer
    INTERNATIONAL BIOMEDICAL, INC.
    Date Cleared
    2002-09-11

    (12 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065) are identical.
    Device Description
    The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present.
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    K Number
    K955766
    Device Name
    ADULT-PEDIATRIC TRANSPORT SYSTEM
    Manufacturer
    INTERNATIONAL BIOMEDICAL, INC.
    Date Cleared
    1996-08-07

    (231 days)

    Product Code
    FPO
    Regulation Number
    880.6910
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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