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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodePDK
Regulation Number 892.6510
Device Class 2