QLE

Protective Barrier Enclosure With Negative Pressure

Product code

QLE

Device name

Protective Barrier Enclosure With Negative Pressure

Device class

Class N

Medical specialty

Unknown

Marketing pathway

EUA - Emergency Use Authorization

FDA classification definition

A barrier device with negative pressure which partially or fully covers a patient to prevent HCP exposure to pathogenic biological airborne particulates. These barrier devices include ports for medical care and/or procedures. Device intended to be used during declared public health emergency.

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