Graduated Compression Hosiery

Compression hosiery marketed with therapeutic claims — such as treatment of chronic venous insufficiency or post-surgical use — may be regulated as a Class I or Class II medical device by FDA, requiring compliance with applicable device registration and labeling requirements. Hosiery sold purely for comfort or fashion compression generally does not trigger FDA device review. Importers should evaluate product labeling and intended-use claims carefully, and consult a regulatory specialist if therapeutic claims are made.

The 67 decitex per single yarn threshold divides fine-gauge synthetic hosiery (below 67 dtex, classified under 6115104000 for non-surgical graduated compression) from coarser-yarn products. Finer yarns are typical of sheer compression stockings, while heavier-gauge products are more common in medical or industrial compression applications. Yarn fineness should be confirmed with the manufacturer's technical specification sheet.