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U.S. Department of Health and Human Services

Product Classification

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Device cream for x-ray attenuation
Definition 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 gloved hand, followed by donning a second glove.The x-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.
Physical State X-ray attenuating cream
Technical Method The device consists of a non-toxic, non-heavy metal, radiation absorbing material in a formulated base. Radiation is blocked by the device via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation absorbing material.
Target Area Healthcare Professional's hands
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodePDK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.6510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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