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SITCSection 6
U.S. imports of sheath contraceptives of rubber (SITC 62911) totaled $6.9M in April 2026, traded with 9 countries.
Importers of Sheath Contraceptives of Rubber paid $479K in duties in April 2026 — an effective duty rate of 10% on $4.8M in dutiable value, based on actual customs collections rather than the published tariff schedule. Sheath Contraceptives of Rubber imports of $6.9M in April 2026 ran 29% above the year-to-date monthly average of $5.4M.
Last updated: April 2026 dataRubber sheath contraceptives (condoms) are regulated as medical devices by the US Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, requiring manufacturers to be registered and products to meet FDA quality system regulations before entry. Each shipment is subject to FDA admissibility review, and products failing dimensional, integrity, or labeling standards may be detained or refused. Importers should ensure that foreign manufacturers hold current FDA device establishment registration and that each lot is accompanied by appropriate conformance documentation. Classification and admissibility determinations for medical devices of this type can be complex; consult a licensed customs broker or FDA-registered import specialist.
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Foreign manufacturers of rubber sheath contraceptives must register their establishment with the FDA as a medical device manufacturer and list their products. Condoms must comply with FDA performance standards covering dimensions, freedom from holes, and packaging/labeling requirements. FDA may conduct facility inspections and can detain shipments from unregistered or non-compliant establishments.
Yes. FDA requires that latex-containing medical devices, including condoms, carry a latex allergy warning statement on the label. Shipments lacking the required warning or bearing non-compliant labeling may be refused entry or subject to relabeling under FDA supervision before release. Importers should review FDA's labeling guidance for latex-containing devices before finalizing packaging with overseas suppliers.
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Monthly import values over time