Breathh, Inc. is registered with the United States Food & Drug Administration (FDA), and our products are listed with the device listings per IIE guidance.

Face Mask Products: Breathh DFM3L; Lutema MP3FM

Intended for use by: General Public

Owner & Operator Number: 10076872

Source: FDA

Notes about IIE Guidance

The IIE Guidance, or the Immediately In Effect Guidance, is public policy posted by the Food and Drug Administration (FDA). This policy regulates personal protective equipment (PPE) such as face masks during the COVID-19 pandemic:

• Achieve maximum regulatory flexibility while assuring products are appropriate for their use.
• Discretion as to certain other FDA requirements
• In effect for the duration of the national emergency

For more information, please visit the FDA.