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U.S. Department of Health and Human Services

Product Classification

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Device radiation attenuating medical glove
Regulation Description 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.
Physical State 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.
Technical Method 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.
Target Area Glove
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOPH
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.6250
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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