Product code QLD

Device name

Protective Barrier Enclosure

Medical specialty

Unknown

Device class

N

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset