| United States | Powder-free medical examination gloves; common sizes S–XL; 3.5–5.0 mil finger thickness; textured fingertips; AQL 1.5 or better. | Medical-use claims generally require establishment registration, device listing, applicable premarket clearance or exemption, English labeling, lot traceability, and an importer of record. Confirm current FDA requirements before shipment. | 4015.12
Rubber gloves for medical use; confirm the complete tariff line with a customs broker. | 18–35 days from major Asian loading ports to the U.S. West Coast; 30–50 days to the East Coast, excluding port delays. | US$0.90–2.20 per 1,000 gloves for ocean freight allocation and destination handling under a full-container shipment. | Customs duty may be low or zero for some medical glove classifications, but the exact rate depends on the complete HTS code, origin, trade remedy measures, and entry date. State sales tax and brokerage are normally additional. | US$32–52 | US$36–62 | FDA documentation gaps, incorrect HTS classification, port congestion, container demurrage, and inconsistent thickness or pinhole performance. |
| European Union | Powder-free examination gloves with medical-device labeling, CE documentation where applicable, EN 455 performance evidence, and a documented quality system. | Compliance with Regulation (EU) 2017/745 is generally required for medical-device claims. Non-EU manufacturers need an authorized representative; technical documentation, declaration of conformity, labeling, and importer obligations must be controlled. | 4015.19 or the applicable CN/TARIC subheading; classification can differ according to material, use, and product construction. | 25–45 days to Northern European ports; 30–50 days to Mediterranean ports, excluding inland delivery and customs clearance. | US$1.10–2.80 per 1,000 gloves for ocean freight allocation, terminal charges, and standard destination handling. | Third-country customs duty is commonly within a mid-single-digit range for relevant glove classifications, but the exact TARIC rate and import VAT depend on product code, origin, and member state. Import VAT is commonly 17–27% and may be recoverable by a registered business. | US$32–52 | US$41–72 before recoverable VAT | Incorrect CE route, incomplete technical file, changing EU customs rates, VAT cash-flow impact, and additional extended-producer or packaging obligations in some countries. |
| United Kingdom | Powder-free nitrile examination gloves with English labeling, batch identification, shelf-life control, and evidence supporting medical-use claims. | Medical devices placed on the Great Britain market require the applicable UKCA or accepted CE route under current transitional arrangements. Northern Ireland follows separate EU-related rules. A UK responsible person may be required for overseas manufacturers. | 4015.19 or the applicable UK Global Online Tariff subheading. | 25–45 days to Felixstowe, London Gateway, or Southampton, plus 1–5 days for inland delivery under normal conditions. | US$1.20–3.00 per 1,000 gloves for freight allocation, port charges, and routine customs handling. | Import duty depends on the UK tariff code and origin. Import VAT is generally 20%; duty deferment or postponed VAT accounting may affect cash flow for eligible importers. | US$32–52 | US$42–73 before recoverable VAT | Using the wrong conformity route, duplicate registration work, post-Brexit customs paperwork, and VAT or duty cash-flow exposure. |
| Canada | Powder-free medical examination gloves with bilingual English/French labeling, lot control, and documented biocompatibility and barrier-performance testing. | Medical gloves are generally regulated as Class II medical devices. The importer and manufacturer should verify licensing requirements, medical-device establishment licensing, device licensing, labeling, and importer responsibilities with Health Canada. | 4015.12 or the applicable Canadian Customs Tariff subheading. | 22–38 days to Vancouver; 30–50 days to Montreal or Halifax, excluding inland rail and customs clearance. | US$1.10–2.70 per 1,000 gloves for ocean freight allocation and destination handling. | Many medical glove entries may qualify for low or zero customs duty, but the final rate depends on tariff classification and origin. GST/HST is normally payable at import and may be recoverable by eligible businesses. | US$32–52 | US$38–66 before recoverable GST/HST | Class II licensing errors, missing French labeling, inland rail delays, cold-weather storage issues, and broker classification mistakes. |
| Australia | Powder-free examination gloves with medical-device labeling, stable packaging, performance testing, and a product specification aligned with local healthcare procurement requirements. | Medical-use gloves generally require inclusion in the Australian Register of Therapeutic Goods before commercial supply. The sponsor, manufacturer evidence, conformity documentation, labeling, and post-market obligations should be reviewed with the TGA. | 4015.12 or the applicable Australian Customs Tariff classification. | 18–30 days to Melbourne or Sydney from major Asian ports; allow additional time for biosecurity, customs, and inland delivery procedures. | US$1.50–3.50 per 1,000 gloves for freight allocation, terminal charges, customs handling, and ordinary inland movement. | Customs duty is often low for qualifying medical products, but the precise rate depends on the tariff code and origin. GST is generally 10% and may be recoverable by registered businesses. | US$32–52 | US$40–69 before recoverable GST | TGA listing delays, biosecurity or documentation holds, long replenishment lead times, and higher inventory carrying costs caused by distance. |
| Japan | Powder-free nitrile examination gloves with Japanese labeling, clear medical-use claims, consistent sizing, and documented quality and chemical-resistance performance. | Medical-device import and marketing requirements may involve a licensed marketing authorization holder, product notification or approval, Japanese-language labeling, and compliance with the Pharmaceutical and Medical Device framework. | 4015.12 or the applicable Japanese Customs Tariff line. | 8–20 days to Yokohama, Tokyo, or Osaka from major Asian ports, excluding clearance and inland delivery. | US$1.20–3.00 per 1,000 gloves for ocean freight allocation and destination handling. | Duty and consumption tax depend on the exact tariff line, origin, and product status. Japan consumption tax is generally 10%; customs duty should be confirmed before contracting. | US$32–52 | US$38–67 before recoverable consumption tax | Japanese-language labeling, local authorization requirements, strict document review, and possible delays caused by product-claim discrepancies. |
| United Arab Emirates | Powder-free examination gloves with English and Arabic labeling where required, medical-use documentation, batch traceability, and heat-resistant packaging for regional storage. | Medical-device registration and importer licensing should be confirmed with the relevant UAE authority and emirate-level requirements. The importer of record normally manages customs, product registration, and local distribution documentation. | 4015.12 or the applicable GCC/UAE customs classification. | 18–30 days to Jebel Ali from major Asian ports, excluding customs clearance and local delivery. | US$1.00–2.60 per 1,000 gloves for freight allocation and destination handling under normal container conditions. | Many general imports are subject to approximately 5% customs duty, subject to classification and origin. UAE VAT is generally 5%; exemptions or special treatment should be verified for medical products. | US$32–52 | US$38–64 before recoverable VAT | Product registration delays, Arabic-labeling gaps, high warehouse temperatures, port storage charges, and demand spikes during public-health events. |
