Breathing appliances, medical face masks & N95 protective respirators Import Duty Rate — HTS 9020.00.9000

Products classified under HTS 9020.00.9000 carry a standard Column 1 General MFN duty rate of 0.0%. When originating from China, an additional Section 301 tariff applies (Exempt / Granted Tariff Exclusions), bringing total estimated duty exposure to 0.0%. In addition to customs duties, formal commercial shipments require payment of CBP's 0.3464% Merchandise Processing Fee (min $33.58, max $651.50).

Precision optical and medical manufacturing in countries such as Japan, Germany, Switzerland, Ireland, or Mexico incurs only the standard Column 1 MFN tariff of 0.0%, avoiding USTR Section 301 punitive duties (Exempt / Granted Tariff Exclusions). Mexican manufacturing under USMCA can qualify for 0% duty-free entry if optical assemblies and electronic housings satisfy North American rules of origin and transformation criteria.

Yes. Protective respiratory equipment and N95 surgical respirators classified under HTS 9020.00.9000 are regulated as medical devices by the US Food and Drug Administration (FDA) and require NIOSH approval where particulate filtration claims are made. Importers must submit valid FDA entry data through ACE, including the Foreign Manufacturer Establishment Registration Number, Device Listing Number, and appropriate 510(k) premarket notification clearance, before CBP will authorize cargo release.

No. The Section 321 $800 duty-free exemption is suspended across all origin countries under 19 CFR 10.151 and 19 CFR 145.31. Even prior to the universal suspension, FDA-regulated medical devices were barred from informal clearance; the current regulation eliminates any ambiguity for HTS 9020.00.9000. All shipments require customs entry, payment of applicable duties (0.0%) and fees, and electronic transmission of FDA compliance documentation (510(k), device listings, or 21 CFR 801.410 drop-ball test certificates). (Regulatory status verified as of Q3 2026; subject to ongoing administrative review).