US Customs has made an exemption for facial masks from China at this time. The duty rate for masks from China and most other countries is 7%, unless we have a free trade agreement with that country. Please email us for more specific questions regarding your product.
Regarding FDA regulations, here is the current guidance regarding importing masks:
This is a very fluid situation and the guidance can change at any time. Please monitor the Coronavirus FDA page for the latest information: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19
At this time, the current guidance on masks is below.
Please see this information N95 and Surgical Masks: https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic-508.pdf
General Purpose Masks, including NIOSH-certified N95 respirators, are not typically regulated by FDA.
Products not regulated by FDA should not be transmitted to FDA and/or should be disclaimed.
Surgical Masks are masks/respirators labeled or marketed as protection against pathogens or for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals is considered a medical device regulated by FDA.
Non-medical masks authorized for use in healthcare settings by healthcare personnel (HCP) to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 are listed in Appendix B of the Emergency Use Authorization.
If you are still unsure, please consult CDRH’s Device Determination Team (devicedetermination@fda.hhs.gov) to determine if the product meets the definition of a medical device.