FDA product code QLD: Protective Barrier Enclosure
QLD is the FDA product code for protective barrier enclosure. It is a Not classified device, reviewed by the General Hospital panel. Devices under QLD reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Protective Barrier Enclosure |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QLD devices
openFDA lists no recalls for product code QLD.
Frequently asked questions
What is FDA product code QLD?
QLD is the FDA product code for protective barrier enclosure. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QLD?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLD
- Run a recall and safety report across every QLD manufacturer
- Watch product code QLD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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