When you read this article, you may going to or have started to import protective gloves and goggles from China. Keep reading for 10 minutes. You will learn about all kinds of inside stories of protective gloves and goggles imported from China.
All the content is very practical and understandable. If you are a newcomer to trade or have more than 20 years of import experience from China, you need to read it carefully. More than 90% of importers are not from the medical product industry before the coronavirus.
The BW team summarized the meeting records of the BW air&sea transportation, customs declaration, and quality control departments and the easiest mistakes and experience summary through the actual supply chain operation for the past 1 month.
This blog will be the most complete and latest article you can find on Google on how to import and ship protective gloves and goggles from China.
Customs clearance requirements for medical gloves and goggles imported from China:
Export qualifications of Chinese suppliers:
The materials of company qualification for the export of medical gloves and goggles required for epidemic prevention and control are basically the same as the export masks:Here
The following is the reference for the export qualification requirements of Chinese suppliers of masks:
Medical gloves and goggles imported from China are classified as follows:
Common protective gloves and goggles should be included in the following tax numbers:
What HS -CODE you should using for glove and goggles ,shipping from China and customs clearance in destination airport:
commodity | Material | Commodity tax number |
protective gloves | Rubber (for surgery) | 40151100 |
Rubber (other) | 40151900 | |
Plastic ( polyvinyl chloride ) | 39262011 | |
Plastic ( other ) | 39262019 | |
goggle |
_ |
90049090 |
Forbidden management of medical gloves and goggles imported from China:
At present, the Ministry of Commerce of China has not set trade control requirements for protective gloves and goggles, and China Customs has special inspection requirements for supervision documents for gloves and goggles shipping from China.
Classification of medical gloves imported from China:
Protective gloves can be divided into nitrile gloves, PVC gloves, latex gloves, and PE gloves according to different materials, and can be divided into medical grade and non-medical grade according to quality grade and use.
Medical grade gloves refer to the need to meet the target national medical market quality certification system Or access standard products, mainly used in medical surgery, medical examination, medical care, and other fields.
Classification comparison of protective gloves | |||
Types of | Main raw materials | Product Features | Main application areas |
Nitrile gloves | But- nitrile latex, and 30 kinds of materials | Good elasticity, strong stretching, acid and alkali resistance, oil resistance, antistatic, non-allergic | Medical examinations, simple medical procedures, hygiene, food processing |
PVC gloves | PVC paste resin, plasticizer, viscosity reducing agent | Easy to wear, good breathability, but stretchability is worse than nitrile gloves | Medical inspection, food processing, sanitation, chemical electronics |
Latex gloves | Natural latex, stabilized natural latex, stabilizer, catalyst | Elasticity and skin- tightness, but collagen may cause allergies | Medical surgery |
PE gloves | Polyethylene | Low price, poor scalability, easy to break | food |
Goggles imported from China:
Goggles prevent some splashes or blood from splashing on the face, thus protecting the eyes. Generally, they are used in conjunction with masks and surgical caps to provide comprehensive protection for the head.
The protective gloves and goggles imported from China, the product access conditions of different countries:
Protective gloves and goggles imported from China to the United States:
You must obtain FDA registration certification from the US Food and Drug Administration before you can sell in the US domestic market.
Ship protective gloves from China to the United States:
Disposable medical gloves, including examination gloves, surgical gloves, and medical gloves for handling chemotherapeutic agents (chemotherapy gloves). These gloves are regulated by the FDA as medical devices, and they need to implement the Premarket Notification in accordance with the requirements of Section 510 (k) of the US Federal Food, Drug, and Cosmetic Act, and apply to the FDA for product marketing approval.
The FDA reviews these devices to ensure that performance standards such as leak resistance, tear resistance, and biocompatibility is met.
Note: On December 19, 2016, the US Food and Drug Administration issued a final rule banning powder gloves, deciding to ban powdered gloves in medical activities, including powdered surgical gloves, examination gloves, and absorbable lubricants Pink surgical gloves.
Ship goggles from China to the United States:
Goggles are usually registered as Class I medical devices, and most products are exempted from 510K. General control is implemented. Enterprises only need to register and list products and implement the GMP standard QSR820 (Some of the products are also exempt from GMP), the products can enter the US market.
Protective gloves and goggles imported from China to the EU
Must obtain EU CE certification and comply with technical regulations: (EU) 2016/425
Protective gloves, goggles and protective clothing imported from China are both personal protective equipment (PPE) and are subject to the EU (EU) 2016/425 technical regulations
. It is important to emphasize the EU regulations (EU) 2016/425 in 2018 Officially implemented on April 21st, withdrawn and replaced the PPE Directive 89/686 / EEC, and pointed out that products placed on the market after April 21st, 2019 must meet all the requirements in (EU) 2016/425. Foreign trade enterprises and production enterprises must pay special attention.
European Union Personal Protective Equipment Regulations (EU) 2016/425 harmonized standards query:
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/personal-protective-equipment_en
Protective gloves and goggles imported from China to Japan
If you need to put products on the market, you must meet Japan’s Pharmaceutical and Medical Device Act (PMD Act). Under the requirements of the PMD Act, the TOROKU registration system requires foreign manufacturers to register manufacturer information with PMDA.
Japan Pharmaceutical and Medical Devices Comprehensive Agency (PMDA) Website: www.pmda.go.jp
Protective gloves and goggles imported from China to South Korea
The legal threshold for medical device access in Korea is basically classified as Class I, II, III, IV, and the license is a Korean company (License holder). The Korean consignee needs to go to the Korea Pharmaceutical Traders Association to file import qualifications in advance. .
Website: www.kpta.or.kr.
At present, the Ministry of Food and Drug Safety of Korea is conducting rapid licensing, and the contact information of the licensing review department is as follows: (Contact to obtain the import business declaration form and product authorization, and quickly process the import request.)
Department | Contact method |
Ministry of Food and Drug Safety
The Fusion Innovation Product Support Group Approves the General Team |
043-719-2333 |
Department of Medicine Safety Management, Seoul Local Food and Drug Administration | 02-2640-1413 |
Department of Medical Product Safety, Busan Regional Food and Drug Administration | 051-602-6187 |
Beijing Ren place KFDA Medical Product Safety Branch | 02-2110-8097 , 8072 |
Tai Qiu local Food and Drug Administration Office of Medical Product Safety Branch | 053-589-2757 |
Department of Medical Product Safety, Gwangju Local Food and Drug Administration | 062-602-1541, 1455 |
Daejeon Regional Food and Drug Administration Medical Product Safety Division | 042-480-8768 |
The “Regulations on the Approval, Notification and Evaluation of Pharmaceutical Supplements” can be found at
https://www.mfds.go.kr/eng/brd/m_27/view.do?seq=70665&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=4
Protective gloves and goggles imported from China to Australia
It must be registered by TGA in Australia. TGA is the abbreviation of Therapeutic Goods Administration.
The full name is Therapeutic Goods Administration. Australia divides medical devices into Class I, Is and Im, Class IIa, IIb, and Class III, which are exemption, filing and registration. Regardless of the type of medical device, it must be approved by the Australian government before it is marketed, meets the basic requirements of medical devices, and is reviewed in accordance with the compliance review process.
Medical gloves and goggles are generally classified as low-medium-risk and low-risk medical devices.
The low-risk medical devices are evaluated by the enterprise itself, as long as they meet the quality and safety conditions, they can enter the market, but relevant documents must be provided to prove their safety and effectiveness. , And enter the medical supplies registration system for number management.
Most devices are managed according to the recording method and check whether they meet the production, labeling and quality standards through a brief evaluation.
Special reminder: Australia has reached a mutual recognition agreement with the EU. This means that the conformity assessment certificate issued by TGA is also recognized by the EU, and TGA also recognizes the EU CE certification.
Users who have obtained CE certification can submit CE certificates and related materials to obtain a TGA certificate.
If the product has been registered or filed, the manufacturer’s replacement of the distributor has no effect on it. After the approval of registration of foreign products, regular registration is required once a year to indicate whether the product model, performance and quality have changed. TGA is solely responsible for conformity evaluation of medical devices and charges a certain fee, the relevant fee amount can be found on the TGA website
How to import protective gloves and goggles from China: find suppliers, risk, quality control
How to find a supplier of medical gloves and googles in China?
1You can use B2B website for example https://www.alibaba.com
2 Via Chinese trading company
Risks of purchasing and importing medical gloves and goggles from China:
70% of B2B’s suppliers are all newly established medical supplies trading companies due to the epidemic situation, so the risk of purchase is very large. We recommend choosing Chinese suppliers who have running operating medical supplies for more than 4 years.
Payment risk:
China’s medical gloves and goggles suppliers often require full payment. It is recommended to negotiate and pay a 30% deposit first, and the remaining payment based on the inspection results.
How to control the quality of medical gloves and goggles imported from China?
1 Luck if you find a good supplier
2 Let BW’s inspection team assist you in controlling medical gloves and goggles’ quality.
How to ship protective gloves and goggles from China:
Transportation route:
Sea freight: Southeast Asia, Japan, South Korea, we recommend shipping by sea.
Air Freight: Airfreight for the delivery of anti-epidemic materials from China, the waiting time for goods in the warehouse, the customs declaration time, the customs clearance time for inspection, and the waiting time for take-off are very long. Please arrange the shipment reasonably according to the order situation of different buyers.
Be sure to choose FOB terms!
FOB suppliers will declare to China Customs through their own companies.
They must provide all the customs declaration information corresponding to their company. If their customs documents or any report is illegal or wrong, their 13% tax refund will be affected.
The Chinese government will refund 13% of the tax refund to Chinese exporters, about 55 days after the goods are exported. Therefore, if the supplier needs to get the money, they must provide all legal and compliant operation procedures and customs documents.
What are the risks of shipping medical gloves and goggles from China?
If you adopt the EXW term, you will be attracted by the low price, but when you declare the goods. You will find that the export of medical gloves has encountered problems because China Customs is currently very strict with the export declaration of medical protective equipment.
For all cargo transportation under EXW terms, overseas buyers find their own freight forwarders, and many freight forwarders cannot provide medically qualified export agents. So all of the export risks is in the buyer,
CIF: If you use the CIF, because the logistics freight is included in the unit price of the product, you do not know how much freight is spent, which is not conducive to the cost control of your supplier.
And the supplier and his freight forwarder plus more profits in logistics costs. Since all the Chinese airlines recently, the air freight billing is based on the customs declaration day’s price, many importers complain about the high EXW and CIF air freight costs, and finally chose BW as their logistics supplier to avoid loss of each cargo Thousands of dollars in logistics losses.
And CIF terms you cannot control which company the supplier uses to submit the medical product declaration. At present, many overseas buyers who make CIF term contact BW when the goods cannot be shipped and the customs declaration fails. At this time, we cannot assist. too late.
Choose BW, which has a strong Chinese network and covers the network in the whole Asian. Choose BW as their freight forwarder in China.
BW services are reflected in compliance, efficiency, professionalism and reasonable price.
Comparison of standards and indicators for disposable medical gloves imported from China:(For production enterprises’ reference)
1Comparison of national standards for disposable medical rubber examination gloves
Disposable medical rubber examination gloves | |||
Country | content | Adoption relationship | |
Chinese standard | GB 10213-2006 “Disposable Medical Rubber Examination Gloves” | ISO 11193.1: 2002 (equivalently adopted) | |
International standard | ISO 11193-1: 2008 + ISO 11193-1: 2008 / AMD 1: 2012 ” Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution + AMD 1 disposable medical examination gloves. The first 1 Part: a glove made of a rubber solution or rubber latex specifications + amendments 1 “ | ||
EU standards | PD CEN / TR 16953: 2017 ” Medical gloves for single use. Guidance for selection “;
EN 455-1 ~ 4 series performance test method standard ” Medical gloves for single-use “ |
||
American standard | ” FDA-Medical Glove Guidance Manual – Guidance ” ;
ASTM D3578-19 ” Standard Specification for Rubber Examination Gloves “ |
||
Japanese Standard | JIS T 9115: 2018 “radiolabeling back to using Inspection Probes · ken consultation with Oligo Rousseau handbags Single-use Rubber Examination Gloves “ | ISO 11193-1: 2008 ( modified ) , ISO 11193-1: 2008 / AMENDMENT 1: 2012 ( modified ) | |
Korean Standard | KS M the ISO 11193-1: 2016 ” 일회용 의료 고무 장갑 – 제 . 1 부 : 고무 라텍스 또는 고무 용액 으로 만든 장갑 에 대한 요구 사항 Single-use Medical Examination Gloves – Part. 1 : Specification for Rubber Gloves Made from LaTeX or Rubber Solution 》 | ISO 11193-1: 2012 ( modified ) | |
Australian Standard | AS / NZS 4011.1: 2014 《Single-use Medical Examination Gloves-Specification For Gloves Made From Rubber Latex Or Rubber Solution 》 | ISO 11193-1: 2008 ( modified ) |
2Comparison of indexes for disposable medical rubber examination gloves
Compare with international standard ISO 11193-1: 2008 + ISO 11193-1: 2008 / AMD 1: 2012 | ||
standard | Dimensions and tolerances | Tensile properties |
Chinese Standard GB 10213-2006 | Inconsistent, Chinese size tolerance is greater than international standards | Inconsistent, the minimum tearing force of category 2 gloves after aging is 7.0N |
International Standard ISO 11193-1: 2008 + ISO 11193-1: 2008 / AMD 1: 2012 | International standard dimensions and tolerances | The minimum tearing force of Category 2 gloves after aging is 6.0N |
EU standard PD CEN / TR 16953: 2017; EN 455-1 ~ 4 | Inconsistent, Europe is oversized | Inconsistent standards |
American Standard ASTM D3578-19 | Partially inconsistent | Inconsistent standards |
Japanese standard JIS T 9115: 2018 | Inconsistent, Japan is undersized | Inconsistent standards, stricter than international standards |
Korean Standard KS M ISO 11193-1: 2016 | No standard text | No standard text |
Australian Standard AS / NZS 4011.1: 2014 | Unanimous | Inconsistent, the minimum tearing force of category 2 gloves after aging is 7.0N |
3Comparison of Chinese and foreign standards for disposable medical PVC examination gloves
Single-use medical PVC examination gloves | |||
Chinese standard | GB 24786-2009 “Disposable PVC Medical Examination Gloves” | Adoption relationship | ISO 11193-2: 2006 (MOD) |
International standard | ISO 11193-2: 2006 “Single-use medical examination gloves — Part 2: Specification for gloves made from poly (vinyl chloride) disposable medical examination gloves. Part 2: Specification for gloves made of polyvinyl chloride | Adoption relationship | |
EU standards | PD CEN / TR 16953: 2017 “Medical gloves for single use. Guidance for selection”;
EN 455-1 ~ 4 series performance test method standard “Medical gloves for single use” |
Adoption relationship | |
American standard | ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application | Adoption relationship | |
Japanese Standard | JIS T 9116: 2018 “ Single-use polyvinyl chloride gloves for dentistry ” | Adoption relationship | ISO 11193-2: 2006 (MOD) |
Korean Standard | The ISO MKS 11193-2: 2009 (Confirm The, 2014) ” 일회용 의료 고무 장갑 – 제 2 부: 폴리 염화 비닐 로 만든 장갑 에 대한 요구 사항 Single-use Medical Examination Gloves-Part 2: Specification for Gloves Made from poly (Vinyl chloride)》 | Adoption relationship | ISO 11193-2: 2006 (IDT) |
Australian Standard | AS / NZS 4011.2: 2014 “ Single-use Medical Examination Gloves-Specification For Gloves Made From Poly (vinyl Chloride) ” | Adoption relationship | ISO 11193-2: 2006 (MOD) |
4Comparison of indicators of disposable medical PVC examination gloves
Comparison with international standard ISO 11193-2: 2006 | ||
standard | Dimensions and tolerances | Tensile properties |
Chinese standard GB 24786-2009 | Unanimous | Inconsistent, changed the index of finger strength before and after aging from 7.0N (6.3.2 in ISO 11193-2: 2006) to 4.8N |
International Standard ISO 11193-2: 2006 | International standard dimensions and tolerances | The finger strength index before and after aging is 7.0N |
EU standard PD CEN / TR 16953: 2017; EN 455-1 ~ 4 | Inconsistent standards | Inconsistent standards |
American Standard ASTM D5250-19 | Partially inconsistent | Inconsistent standards |
Japanese standard JIS T 9116: 2018 | Inconsistent, Japanese size (width) is too small | Inconsistent standards |
Korean Standard KS M ISO 11193-2: 2009 | Unanimous | Unanimous |
Australian Standard AS / NZS 4011.2: 2014 | Unanimous | Unanimous |
5Comparison of Chinese and foreign standards for disposable surgical gloves
Disposable surgical gloves | |||
Country | content | Adoption relationship | |
Chinese standard | GB / T 24787-2009 “Disposable non-sterile rubber surgical gloves”; | ||
GB 7543-2006 “Single-use sterile rubber surgical gloves” | ISO 10282: 2002 (equivalent use) | ||
International standard | The ISO 10282:, 2014 ” Single-use Sterile Rubber Surgical Gloves – Specification disposable sterile rubber surgical gloves. specification” | ||
EU standards | PD CEN / TR 16953: 2017 ” Medical gloves for single use. Guidance for selection “;
EN 455-1 ~ 4 series performance test method standard ” Medical gloves for single use “ |
||
American standard | To ASTM D3577-19 ” Standard Specification for Rubber Surgical, Gloves “ | ||
Japanese Standard | JIS T 9107: 2018 “ Single-use sterile rubber surgical gloves- Specification ” | The ISO 10282:, 2014 modified employed ) | |
Korean Standard | KS M ISO 10282: 2016 《일회용 멸균 수술 용 고무 장갑 – 요구 사항 Single-use sterile rubber surgical gloves – Specification 》 | ISO 10282: 2014 ( equivalent ) | |
Australian Standard | AS / NZS 4179: 2014 《Single-use Sterile Rubber Surgical Gloves- Specification 》 | ISO 10282: 2014 ( revised ) |
6Index comparison of disposable surgical gloves
Comparison with international standard ISO 10282: 2014 | ||
standard | Dimensions and tolerances | Tensile properties |
Chinese Standard GB 7543-2006 | Unanimous | Unanimous |
International standard ISO 10282: 2014 | International standard dimensions and tolerances | The international standard tensile performance index |
EU standard PD CEN / TR 16953: 2017; EN 455-1 ~ 4 | Inconsistent standards | Inconsistent standards |
American Standard ASTM D3577-19 | Partially inconsistent | Inconsistent standards |
Japanese standard JIS T 9107: 2018 | Unanimous | Unanimous |
Korean Standard KS M ISO 10282: 2016 | Unanimous | Unanimous |
Australian Standard AS / NZS 4179: 2014 | Unanimous | Unanimous |
In addition to the indicators listed in the table, international standards and national standards are generally consistent in basic characteristics such as glove classification and materials used.
Comparison of standards and indicators of imported goggles imported from China
The production of eye protection products in China mainly adopts the mandatory national standard GB 14866-2006 “Technical Requirements for Personal Eye Protectors”. The standard specifies the optical performance, impact resistance, heat resistance, corrosion resistance, irritant gas protection, and other technical performance requirements and corresponding test methods for personal eye protectors.
It is applicable to nuclear radiation, X-ray, laser, ultraviolet, infrared and Various types of personal eye protectors other than radiation. According to the shape of the protective gear, it can be divided into glasses, eye masks, and face masks, and the lenses are divided into organic lenses and inorganic lenses.
Eye protectors should be able to provide protection and counteract:
1) The shock of different intensities, 2) Visible light radiation, 3) Molten metal splash, 4) Liquid mist and splash, 5) Dust, 6) Irritant gas and other injuries or functions of these types of harmed persons and combinations.
The US NFPA 1999 stipulates that if the part of the disposable eye protection product covering the eyes is not a whole piece of plastic or solid film, the material used for the eye protection product should be subjected to a microbial penetration tests. In addition, liquid integrity test and visual fogging test are also required. If fabrics are used in the eye protection products, the flammability test shall be carried out for each layer of fabric, and the flame propagation time shall be more than 3.5 seconds.
American Standard ANSI Z87.1-2015 “Personal Eye and Face Protection Equipment for Occupation and Teaching” is applicable to welding protective goggles, goggles, face masks and other products, and specifies the optical requirements, physical properties, and minimum lenses for eye protection Thickness, impact resistance and protection requirements for light radiation, liquid mist and splashes, dust, etc.
Goggles technical standards of various countries
Country | Standard | English name | |
International | ISO 4849-1981 | Personal eye -protectors; Specifications | |
ISO 12609-1-2013 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications-Part 1: Specification for products | ||
EU | EN 166-2001 | Personal Eye -Protection-Specifications | |
United States | ANSI Z87.1 | Practice for Occupational and Educational Eye and Face Protection | |
ASTM F 2100 | Standard Specification for Performance of Materials Used in Medical Face Masks | ||
Japan | JIS T8147-2016 | Personal eye protectors | |
Korea | KS G ISO 12609-1-2014 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products |
Import and ship COVID-19 test kit, medical masks, medical protective clothing, ventilator, infrared thermometer,protective gloves, goggles from China.
One-stop guide&unserstanding, update 2020, All you need to know!(All legal, with all types of supplier resources attached!)