QLE — Protective Barrier Enclosure With Negative Pressure Class N
FDA product code QLE covers "Protective Barrier Enclosure With Negative Pressure", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QLE
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Unknown
- Implant
- No
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.