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VietTakara is a manufacturer of masks and equipment to produce masks with the best price and quality in Vietnam.

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 What are the requirements for exporting masks to Europe and the US?

What are the requirements for exporting masks to Europe and the US?

To export masks to world markets such as the US, UK, European Union EU, Japan, Korea, Spain, Italy, etc., these masks need CE and FDA certificates.

What is CE certification?

CE (abbreviated from Conformité Européenne – In French. CE marking is extremely important, a product with CE certification is eligible for circulation in Europe. 

CE certification mark

So if you want to know if the quality of the mask you buy is a mask according to export standards, you can check the CE certification on the product. 

The process for masks to be CE certified is also extremely complicated, but includes 3 main points.

  • The product fulfills the requirements of the European product directive
  • Meets recognized European harmonized performance and safety standards
  • Fit for its purpose and will not endanger life or property.

What is FDA certification?

FDA (Food and Drug Administration), this is the US Food and Drug Administration. FDA was established in 1906, headquartered in White Oak, Maryland. All products that want to be exported to the US market must have FDA certification.

If there is no FDA certification for the product, it cannot be exported to the US. Each FDA certificate will be made individually for each type of product. FDA does not print on the product, but masks that want to be exported to the US market will need an FDA certificate.

In order for a product of an enterprise to be granted the FDA certificate, it is necessary to have a process, standards in production, management ... according to American standards. 

What is the standard structure of the mask?

Regarding the structure of standard masks, there are two types: 3-layer and 4-layer.

  1. Green non-woven fabric.
  2. Filter screen
  3. Antibacterial Cloth or Antibacterial Paper
  4. White non-woven fabric.

Image: 4-layer structure of a medical mask.

In which layer 3 is antibacterial cloth or antibacterial paper is the most important. In addition, according to the recommendations and certification of the Ministry of Health, there is an antibacterial cloth mask called SMS used for production and export.

What is SMS antibacterial fabric?

SMS stands for "Spunbond + Meltblow + Spunbond NonwovensIt is a 3-layer nonwoven fabric that is combined from 2 outer layers of spunbond and 1 inner meltblown nonwoven. With the interlaced structure, the filter is the highest, reaching the international standards, so it is the most widely used in this industry.

SMS antibacterial fabric image.

What type of mask on the market has CE, FDA and uses SMS antibacterial fabric.

All masks on the market, whether cloth or medical, with or without an antibacterial layer can block dust. However, a mask with an antibacterial layer can block dust, bacteria, toxic gases H2S, SO2, CO, HN3 ... 90% higher than other common masks.

This is one of the few masks on the market that meets CE and FDA certification standards.

How to check the standard mask simply?

Based on the characteristics of the fabric layers that make up the mask, there are two simple ways.

Step 1: Tear off 1 mask, check if there are enough 4 layers.

Step 2: Please pour water into the mask, check the water resistance. Standard masks are not waterproof.

Step 3: Burn the antibacterial fabric, its properties when burned will shrink but still retain the inherent white color, it is a good quality mask. And if when you burn it, you see that antibacterial paper, if it is burned to charcoal, it is a fake mask.

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