Disposable gloves come in handy in many situations. Single-use gloves are used for hand and arm protection, mainly in household cleaning, medical, forensic, automotive, scientific, food service, and industrial applications. Amidst the coronavirus pandemic, we see a great interest in importing single-use gloves from China. Therefore, we have prepared a guide for importers.
Importing single-use gloves from China – production areas
The largest manufacturers of surgical gloves can be found in Guangdong Province in southern China. Zhejiang Province is the second best place to import gloves, followed closely by Shandong. You can also find suppliers in Fujian, Jiangsu, and Shanghai.
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Importing single-use gloves from China – EU customs duties
The EU customs tariff can be checked in the Tariff of the European Union TARIC. The site is available in many European languages and is very user-friendly.
The duty on various gloves:
- Plastic gloves – 3926 20 00 – 6.5%
- Surgical gloves – 4015 11 00 00 – 2%.
- Textile gloves – 6216 00 – 7.6%
- Other rubber gloves – 4015 19 00 – 2.7%
- Gloves impregnated, coated or covered with rubber – 6116 10 20 – 8%
- Other impregnated gloves, coated or covered with plastics or rubber – 6116 10 – 8.9%
The importer’s obligations in the EU
The most popular medical gloves are made of nitrile, i.e., synthetic rubber. Disposable nitrile gloves can be divided into industrial and medical grades. Depending on their intended use, gloves require other tests and compliance with relevant standards.
First of all, you must have CE certification for all medical-grade disposable gloves imported from China.
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Medical gloves made of nitrile must meet compliance with the EN test and safety requirements. Disposable medical gloves must comply with EN 455. The standard specifies requirements and testing of gloves for freedom from leaks, physical properties, biological evaluation, and determination of shelf life. Such gloves can be used for medical applications like healthcare, dentistry, and pharmaceuticals. Protective gloves against chemicals and micro-organisms must comply with EN 374:
- Terminology and performance requirements for chemical risks – EN 374-1
- Determination of resistance to penetration – EN 374-2
- Determination of resistance to permeation by chemicals – EN 374-3
- Determination of resistance to degradation by chemicals – EN 374-4
- Terminology and performance requirements for micro-organisms risks – EN ISO 374-5.
Gloves for contact with food (HDPE) made mostly of plastic must meet the requirements of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of October 27, 2004, on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC with regard of Commission Regulation (EU) 2019/1338 of August 8, 2019.
At all times, these products must not cause penetration into the food of substances (BPA, phthalates, and other substances covered by EN 13130) in quantities that may cause a hazard to human health and cause undesirable changes in the composition of such food. Materials and products that have not yet come into contact with food and are intended to must have a wine glass and a fork symbol.
The tariff and the importer’s obligations in the US
One of the importer’s obligations is the payment of customs duties. Below we present HS codes and customs rates for disposable gloves. The products are listed in the Harmonized Tariff Schedule System.
- Surgical gloves – 4015.11.01 – 0%
- Medical gloves – 4015.19.05 – 0%
- Plastic protective gloves – 3926.20.10 – 0%
In terms of importing single-use gloves from China, you must obtain the FDA registration certification of the US Food and Drug Administration before you can sell in the US domestic market. The FDA reviews these goods to ensure that performance standards, such as leak resistance, tear resistance, and biocompatibility, are met. Gloves regulated by the FDA as medical devices, like examination gloves and surgical gloves, need to implement the Premarket Notification under the requirements of Section 510 (k) of the US Federal Food, Drug, and Cosmetic Act and apply to the FDA for product marketing approval.
Note: On December 19, 2016, the US Food and Drug Administration issued a final rule banning powder gloves in medical activities, including examination gloves, powdered surgical gloves, and absorbable lubricants pink surgical gloves.
Overall, imported products must comply with applicable regulations as well as standards. Otherwise, the goods cannot be admitted to trading on the US market. Moreover, the product has to meet the labeling requirements. The wine glass and a fork symbol is also used in North America.
Beware of fraud
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Be mindful when choosing a business partner from China. There has been a rise in the number of scammers, especially on Alibaba. We can verify your potential partner and goods’ certifications for you.
Remember to verify certification for protective and medical goods. Due to the growing number of fraudsters, the Chinese government has implemented a regulation regarding the export of protective products and medical devices. The product or device must be registered in China after obtaining a medical product registration certificate. While making a deal, a Chinese exporter must provide a registration number. In addition, according to the regulation, the goods must comply with the quality standards of the importing country.
The above regulation does not apply to HDPE gloves, which are classified as food contact products, not medical devices.
Protective gloves without CE and other mandatory conformity documents cannot be legally placed on the EU market. Goods and documentation are thoroughly checked at customs. If any inaccuracies are found, the customs office may confiscate the goods and impose a financial penalty. To prove that the CE mark is real, the supplier is required to provide you a test report. Also, the report should have a number issued by the body issuing the document. You should be able to find the same number on the issuing body’s site. If it is on the official website of the issuer of the CE document, it means that the marking is genuine.
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Source: https://t-tees.com
Category: HOW
