QLD

Protective Barrier Enclosure

Product code
QLD
Device name
Protective Barrier Enclosure
Device class
Class N
Medical specialty
Unknown
Marketing pathway
EUA - Emergency Use Authorization

FDA classification definition

A transparent device designed to cover a patient's head and upper body and incorporates one or more ports through which the HCP's hands are passed to perform medical procedures. Device provides extra layer of barrier protection, in addition to PPE, during the declared public health emergency.

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

Official FDA classification page: QLD
Classification and pathway per current FDA publications. Data from openFDA (CC0).