Mask, Surgical, Eua Authorized
The Surgical Mask (EUA Authorized) is a physical barrier device intended for use by healthcare personnel as personal protective equipment (PPE) in healthcare settings to prevent exposure to respiratory droplets and large particles during surgical mask shortages arising from a declared public health emergency. It was authorized under an FDA Emergency Use Authorization (EUA) rather than through the standard premarket pathway, and is therefore not formally classified. Product code QMF, reviewed by the General Hospital panel. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QMF
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- HO
- Submission Type
- 8
Device Characteristics
Definition
Surgical masks for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the declared public health emergency. Surgical masks that have been designed, evaluated, and validated consistent with the conditions set forth in FDA's EUA Authorization letter for these devices and that are not excluded from the scope and are not authorized under the EUA.
Unclassified Reason
11
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.