Standard International Trade Classification
U.S. imports of Pharmaceutical-Impregnated Bandages & Medical Dressings (SITC 54191) totaled $148.0M in August 2026, imported from 56 countries.
Importers of Pharmaceutical-Impregnated Bandages & Medical Dressings paid $14.2M in duties in August 2026, an average duty rate of 9.62% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule.
Last updated: August 2026 dataWadding, gauze, and bandages that are impregnated or coated with pharmaceutical substances — such as antiseptics, antibiotics, or hemostatic agents — or that are packaged in retail form for medical, dental, or veterinary use are classified here rather than as plain textile goods or bulk pharmaceuticals. FDA regulates many of these products as combination products or medical devices, depending on the primary mode of action of the pharmaceutical coating, which can affect the premarket review pathway required before US market entry. Importers should determine at the outset whether a coated dressing is classified by FDA as a drug, device, or combination product, as each pathway carries distinct 510(k), PMA, or NDA requirements.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
9.9K import shipments a month
FDA applies a primary mode of action test: if the pharmaceutical ingredient provides the primary therapeutic effect, the product is regulated as a drug (or combination product with drug lead); if the physical structure of the dressing is primary and the coating is secondary, it may be regulated as a device. This determination drives which premarket submission — NDA, 510(k), or PMA — is required, and importers should seek an FDA combination product designation if the classification is unclear.
No. Veterinary-use pharmaceutical dressings are regulated by FDA's Center for Veterinary Medicine (CVM) rather than CDER or CDRH. The applicable approval or clearance pathway, labeling requirements, and establishment registration obligations differ from those for human-use products, so importers must identify the intended species of use before determining the correct regulatory route.
Basic heading 22 of 465 in section 5
Basic heading 54191 · $148.0M of $27.5B
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ImportsExports
Imports
$148.0MYoY · free account
Exports
$113.6MYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $1.8B of Pharmaceutical-Impregnated Bandages & Medical Dressings and exported $1.4B.
Through August 2026. Source: U.S. Census Bureau.
Imports · August 2026
origin
China and Mexico together supply 51% of it. South Korea pays 12.5% duty; Mexico 0.1%.
customs district
Census does not publish district detail for this classification system.
destination
Census does not publish state detail for this classification system.
entry
Census does not publish port detail for this classification system.