← FDA Medical Device Classifications

Protective Barrier Enclosure

QLD · Not classified · Unknown

Classification

FDA Product Code
QLD
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 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.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown