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510(k) Data Aggregation
K Number
K022873Device 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
878.4460Why 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
K022876Device Name
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
Manufacturer
INTERNATIONAL BIOMEDICAL, INC.
Date Cleared
2002-09-11
(12 days)
Product Code
FPL
Regulation Number
880.5410Why 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
K955766Device Name
ADULT-PEDIATRIC TRANSPORT SYSTEM
Manufacturer
INTERNATIONAL BIOMEDICAL, INC.
Date Cleared
1996-08-07
(231 days)
Product Code
FPO
Regulation Number
880.6910Why 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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