40151200
4›Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanised rubber other than hard rubber
Of a kind used for medical, surgical, dental or veterinary purposes
Standard EU duty
2%
VAT
23%
Additional duties / sanctions
0 rules
Docs required
6 docs
N954U045U078U079Y997Y984
Standard rates
| Applies to | Type | Rate | Conditions | Regulation |
|---|---|---|---|---|
| ERGA OMNES | Third country duty | 2% | — | R1832/21 |
Preferences
AD 0%AL 0%BA 0%CA 0%CAMER 0%CARI 0%CH 0%CI 0%CL 0%CM 0%CO 0%DZ 0%EBA 0%EC 0%EEA 0%EG 0%EH 0%ESA 0%EUCA 0%FJ 0%FO 0%GB 0%GE 0%GH 0%GSP 0%GSP+ 0%IL 0%JO 0%JP 0%KE 0%KR 0%LB 0%LOMB 0%MA 0%MD 0%ME 0%MK 0%MX 0%NZ 0%PE 0%PG 0%PS 0%SADC EPA 0%SB 0%SG 0%SM 0%SWITZ 0%SY 0%TN 0%TR 0%UA 0%VN 0%WS 0%XC 0%XK 0%XL 0%XS 0%ZA 0%
Notes
CD303The relief from or reduction of customs duties shall be subject to the specific request expressed by the declarant in box 44 "Additional information/Documents produced/Certificates and authorisations", of the Single Administrative Document (SAD)
TM904Preferences granted under the agreement between the European Union and Morocco in force from 19 July 2019.As of 3 October 2025, products originating in Western Sahara subject to controls by the customs authorities of the Kingdom of Morocco shall benefit from trade preferences under the terms of the new Agreement in the form of exchange of letters between the EU and Morocco, The European Union and the Kingdom of Morocco have agreed to allow those products to be identified by reference to the region of origin to be included in the proof of origin and as provided for in Protocol 4.In view of the application of these measures, the origin certificates codes U179 and U180 must be declared.The country code to be entered in the origin declaration when these proofs of origin are used is “EH”.
CD727Eligibility to benefit from this preference is subject to the presentation of an origin declaration stating the European Union origin of the goods, in the context of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA).
CD906The list of non-eligible locations and their postal codes is available at the following address: http://ec.europa.eu/taxation_customs/customs/technical-arrangement_postal-codes.pdf
CD500Eligibility to benefit from this preference is subject to the presentation of a proof of origin stating the community origin of the goods, in the context of the agreement between the European Union and the Swiss Confederation.
Import controlUAR0692/14
Import control
UAR0692/14
Documents / references
N954U045U078U079Y997
Conditions
- Y001Other conditions: Y997— Import allowed
- Y002Other conditions: U078— Import allowed
- Y003Other conditions: U079— Import allowed
- Y005Other conditions: N954— Import allowed
- Y007Other conditions: U045— Import allowed
- Y009Other conditions: the condition is not fulfilled— Import is not allowed
Notes
- CD967I. According to Council Regulation (EU) No 692/2014, it shall be prohibited to import into European Union goods originating in Crimea or Sevastopol.The prohibition shall not apply in respect of goods originating in Crimea or Sevastopol which have been made available to the Ukrainian authorities for examination, for which compliance with the conditions conferring entitlement to preferential origin has been verified and for which a certificate of origin has been issued in accordance with the Association Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part.II. According to the Council Regulation (EU) 692/2014, the export of goods and technologies suited for use in the sectors of transport; telecommunications; energy; prospection, exploration and production of oil, gas and mineral resources is prohibited:(a) to any natural or legal person, entity or body in Crimea or Sevastopol, or(b) for use in Crimea or Sevastopol.
Import controlUAR0263/22
Import control
UAR0263/22
Documents / references
N954U045U078U079Y984
Conditions
- Y001Other conditions: Y984— Import/export allowed after control
- Y002Other conditions: N954— Import/export allowed after control
- Y005Other conditions: U045— Import/export allowed after control
- Y006Other conditions: U078— Import/export allowed after control
- Y007Other conditions: U079— Import/export allowed after control
- Y009Other conditions: the condition is not fulfilled— Import/export not allowed after control
Notes
- CD860According to Council Regulation (EU) 2022/263 (OJ L42I, p. 77):I. It shall be prohibited to import into the European Union goods originating in non-government controlled areas of the Donetsk, Kherson, Luhansk and Zaporizhzhia oblasts of Ukraine.The import prohibitions not apply in respect of: (a) the execution until 24 May 2022 of trade contracts concluded before 23 February 2022, or of ancillary contracts necessary for the execution of such contracts, provided that the natural or legal person, entity or body seeking to perform the contract has notified, at least 10 working days in advance, the activity or transaction to the competent authority of the Member State in which they are established; (b) goods originating in the specified territories which have been made available to the Ukrainian authorities for examination, for which compliance with the conditions conferring entitlement to preferential origin has been verified and for which a certificate of origin has been issued in accordance with the EU-Ukraine Association Agreement.II. It shall be prohibited to sell, supply, transfer or export goods and technology listed in Annex II to Council Regulation (EU) 2022/263: (a) to any natural or legal person, entity or body in the specified territories, or (b) for use in the specified territories. Annex II shall include certain goods and technologies suited for use in the following key sectors: (i) transport;(ii) telecommunications;(iii) energy; (iv) the prospecting, exploration and production of oil, gas and mineral resources. The prohibitions in point II above shall be without prejudice to the execution until 24 August 2022 of an obligation arising from a contract concluded before 23 February 2022, or from ancillary contracts necessary for the execution of such contracts, provided that the competent authority has been informed at least five working days in advance.
Value Added Tax (VAT)
V020Medical devices, as defined by the Act on Medical Devices of 20 May 2010, (Journal of Laws of 2019, item 175, 447, 534), released for free circulation on the territory of the Republic of Poland
8%V120For medical devices referred to in item 13 of Annex No. 3 to the Act in the wording applicable before the date of entry into force of the Act of 7 April 2022 on medical devices (Journal of Laws, item 974), the tax rate referred to in Art. 41 sec. 2 shall apply if, in accordance with: 1) Art. 120 sec. 4 of the regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Official Journal of the European Union L117 of 5 April 2017) or 2) Article 110 paragraph 4 of the regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Official Journal of the European Union L117 of 5 April 2017) – these products have been placed on the market and are still being made available on the market or put into use.
8%V999Other
23%5
Binding Tariff Information
BTI classification examples
DEgold002/25-1
Medical examination gloves, nitrile rubber, disposable
nitrilkautschuk (NBR)GRI 1GRI 6
DEgold512/25-1
Disposable nitrile rubber gloves for medical use
rubberGRI 1GRI 6
DEgold671/23-1
Surgical nitrile rubber gloves
rubberGRI 1GRI 6
DEgold901/21-2
Disposable latex gloves for medical use
latexGRI 1GRI 6
ESgold5REN1241
Single-use nitrile examination gloves
acrylicGRI 1GRI 6
BTI (Binding Tariff Information) is an official EU customs decision confirming the classification of goods. Valid for 3 years, binding across all EU member states.
What are medical rubber gloves under CN 401512
CN code 401512 covers disposable and reusable gloves made of vulcanised rubber intended for medical and healthcare applications. This classification includes surgical gloves used in operating theatres, diagnostic and examination gloves used during medical examinations, dental gloves protecting dentists and patients, and veterinary gloves used by veterinary practitioners. These products must meet stringent standards concerning leak-tightness, wall thickness and freedom from allergenic chemical substances. They are typically produced from natural latex, nitrile or neoprene. A key requirement is certification as a medical device confirmed by CE marking and compliance with EN 455 for medical gloves or equivalent standards. These gloves are imported mainly from East and South-East Asian countries, including Malaysia, Thailand and China.
Applications and technical requirements for medical gloves
Medical gloves covered by CN code 401512 must guarantee a protective barrier against biological, chemical and infectious agents. In surgery, sterile gloves with enhanced fit precision are used, providing adequate tactile sensitivity. Examination gloves, though not necessarily sterile, must be hole-free and provide leak-tightness confirmed by AQL testing. In dentistry, gloves enabling precise work and resistant to disinfectants are required. In veterinary practice, long protective gloves reaching the elbow have gained popularity. An important aspect when importing is the declaration of conformity, medical device technical documentation and registration in the EUDAMED database. Products marked exclusively for non-medical use are subject to a different tariff classification.
Tariff classification and trade in medical gloves
Medical gloves under CN code 401512 are subject to intensive international trade, particularly since the COVID-19 pandemic dramatically increased global demand for personal protective equipment. When importing from countries outside the European Union, correctly determining the applicable customs duty rate and any tariff preferences arising from trade agreements is essential. The classification of the product as a medical device can significantly affect the VAT rate applied in the destination country. Attention must be paid to Medical Device Regulation requirements governing the placement of such products on the EU market. Compliance with sanitary requirements, quality certificates and declarations of conformity are indispensable both for importation and distribution within the European Union.
Frequently asked questions
Are nitrile medical gloves classified under CN code 401512?
Yes, nitrile gloves intended for medical purposes, including surgical, diagnostic and dental use, are classified under CN code 401512 provided they meet the definition of a medical device. Nitrile is a synthetic rubber and is subject to the same classification as natural latex. The key criterion is the medical intended purpose of the product confirmed by appropriate certification, rather than the material itself.
What documents are required when importing medical gloves into the EU?
Importing medical gloves into the EU requires an EU declaration of conformity, medical device technical documentation, a notified body certificate for Class II and above, registration in EUDAMED, and CE marking. Test reports confirming compliance with EN 455 or an equivalent standard and manufacturer documentation are also necessary. Absence of these documents may result in the goods being detained at the border by customs authorities or market surveillance bodies.
How are medical gloves distinguished from non-medical gloves for customs purposes?
The main criterion is the intended purpose of the product as confirmed by documentation. Medical gloves carry CE marking as a medical device, a device registration number and a declaration of conformity with the MDR or former MDD. Non-medical gloves such as household or industrial gloves do not carry such certification. Customs authorities may verify the actual intended use based on labels, technical documentation and information provided by the manufacturer or importer.
Useful tools & resources
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