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QLENot classified

Protective Barrier Enclosure With Negative Pressure

Unknown
FDA source (opens on fda.gov)

QLE is the FDA product code for Protective Barrier Enclosure With Negative Pressure. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QLE
Device name
Protective Barrier Enclosure With Negative Pressure
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QLE.