← FDA Medical Device Classifications

Mask, Surgical, Eua Authorized

QMF · Not classified · Unknown

Classification

FDA Product Code
QMF
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

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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