OEA

Non-Surgical Gown

Product code

OEA

Device name

Non-Surgical Gown

Device class

Class 1

21 CFR

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K) Exempt

FDA classification definition

A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material

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