IWP

Radiographic Protective Glove

Product code

IWP

Device name

Radiographic Protective Glove

Device class

Class 1

21 CFR

21 CFR 892.6500

Medical specialty

Radiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -

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