# Protective Barrier Enclosure With Negative Pressure
> **Product code: QLE** · Not classified · Unknown · —
## Classification
- **FDA Product Code:** QLE
- **Device class:** Not classified
- **Regulation:** —
- **Review panel:** HO
- **Medical specialty:** Unknown
- **Submission type:** 8
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QLE)
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