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