Protective Barrier Enclosure With Negative Pressure
QLE · Not classified · Unknown
Classification
FDA Product Code
QLE
Device class
Not classified
Regulation
—
Review panel
HO
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.