Product code
QKR: Face mask within the scope of the face mask and barrier face covering enforcement policy or face mask umbrella eua
FDA product code · Not Classified · General Hospital
Key facts
| Product code | QKR |
|---|---|
| Device | Face mask within the scope of the face mask and barrier face covering enforcement policy or face mask umbrella eua |
| Device class | Not Classified |
| Review panel | General Hospital |
| Submission type | Enforcement Discretion |
| GMP exempt | Yes |
| Definition | Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks, Surgical Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the… |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database