FDA product code QLE: Protective Barrier Enclosure With Negative Pressure
QLE is the FDA product code for protective barrier enclosure with negative pressure. It is a Not classified device, reviewed by the General Hospital panel. Devices under QLE reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Protective Barrier Enclosure With Negative Pressure |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QLE devices
openFDA lists no recalls for product code QLE.
Frequently asked questions
What is FDA product code QLE?
QLE is the FDA product code for protective barrier enclosure with negative pressure. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QLE?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLE
- Run a recall and safety report across every QLE manufacturer
- Watch product code QLE 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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