Face Masks

N95 Respirators and Surgical Masks (Face Masks), Filtering Facepiece Respirators (FFRs), are Personal Protective Equipment (PPE) and medical devices.

Keep that in mind before you import these products from China, India, South Korea, or any other countries.

Manufacturers, exporters, Initial U.S. Importers must be registered with the FDA as Medical Device Establishment. Current FDA fee is $5,236.00 (expected to increase on October 1, 2020), whether a Premarket Notification 510(k) is needed or not.

Make sure your company has a DUNS Number.

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