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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radiation attenuating medical glove
Regulation Description Non-powdered patient examination glove.
Definition Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.
Product CodeOPH
Regulation Number 880.6250
Device Class 1

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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