OPH

Radiation Attenuating Medical Glove

Product code

OPH

Device name

Radiation Attenuating Medical Glove

Device class

Class 1

21 CFR

21 CFR 880.6250

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).