inforMED
OPHClass I

Radiation Attenuating Medical Glove

General Hospital · 21 CFR 880.6250

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.

MDR events2All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances0All time

Event type breakdown

Unspecified1
Malfunction1

Recalls

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510(k) clearances

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No 510(k) clearances on file for this product code.