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510(k) Data Aggregation
K Number
K133684Device Name
ULTRABLOX
Manufacturer
BLOXR CORPORATION
Date Cleared
2014-01-13
(42 days)
Product Code
PDK
Regulation Number
892.6510Why did this record match?
Product Code :
PDK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-ray Attenuating Cream has the same intended use, and indications for use as before, with the addition of indications for use with poly-isoprene surgeon's gloves as below:
The X-ray Attenuating Cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures.
NOTE: For use with natural rubber latex and latex-free poly-isoprene Surgeon's Gloves only.
Device Description
The X-ray Attenuation Cream is a sterile cream intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuation Cream is intended for use during medical procedures in which hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 KVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. The X-ray Attenuation Cream is not intended to be used in the primary beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.
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K Number
DEN120022Device Name
X-RAY ATTENUATING CREAM
Manufacturer
BLOXR CORPORATION
Date Cleared
2013-05-09
(183 days)
Product Code
PDK
Regulation Number
892.6510Why did this record match?
Product Code :
PDK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-ray Attenuating Cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. X-ray Attenuating cream is not intended to be used in or adjacent to the primary x-ray beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.
Device Description
The subject device is an X-ray attenuating cream that utilizes bismuth oxide powder as the X-ray absorber material. The subject device is provided sterile in a tube for single use. The end user is to squeeze all of the cream out, either directly to the health care professional's hands or onto a surgical glove before donning a second glove. The device provides protection from X-rays and scatter radiation during procedures where the health care professional's hands are necessarily exposed to radiation.
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