The distinction is based on the glove's design and intended use. Gloves specifically manufactured and labeled for medical, surgical, dental, or veterinary use—meeting sterility or examination-grade standards—classify under 401512. Industrial, household, or chemical-resistant gloves not designed for medical use go under 401519. FDA device classification and the manufacturer's labeling are strong indicators, but the HTS heading text and CBP guidance control the customs classification.

Importers should be prepared to provide evidence of the foreign manufacturer's FDA establishment registration, the device listing number, and the applicable 510(k) clearance or premarket approval. FDA may detain shipments for examination or sampling; having a prior notice filing and a US agent of record for the manufacturer in place speeds clearance. Consult a licensed customs broker or regulatory counsel experienced with FDA device imports.