FDA product code OPH

Radiation Attenuating Medical Glove

General Hospital·Class 1·21 CFR 880.6250
US regulatory classifications
US Product Code (FDA)
OPH
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 880.6250
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Radiation Attenuating Medical Glove is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.