Buda-U Face Mask Put into the White Lists By Both the USA FDA and the Chinese Ministry of Commerce Respectively.

January 28, 2022

Latest company news about Buda-U Face Mask Put into the White Lists By Both the USA FDA and the Chinese Ministry of Commerce Respectively.






Mask Export – Qualification is the Key


Since the beginning of the year, masks have become an issue that increasingly causes people’s attention and it is indeed, an important protection product. This has resulted in a large number of mask manufacturers emerging in China.



At present, the supply of masks in China will not be as short as that of the beginning of the year. Yet, abroad, especially in Europe and the United States and other countries, the epidemic is still severe, and the demand for masks is still huge. The export of masks therefore, provides opportunities for Chinese mask manufacturers.



Maybe we often hear some "titles" about masks, such as KN95 mask, N95 mask and FFP2 mask etc. Then, What's the difference? In fact, Masks are categorized as medical and personal protection equipment, thus, it must meet the corresponding national standards.


As we all know, each country has its own mask standards. For example, take the foldable or cup-shaped protective mask (anti particulate respirator) as an example. China's standard is GB2626-2006. Those with a particulate matter filtration rate of 95% or more are generally verbally called KN95 in China. In fact, "95" indicates the filtration level of our protective mask.


The United States has its own standard or daily address for such corresponding products, namely N95. While, For the EU countries, the similar type of product at this protection level is called as FFP2.



In fact, the export of masks is not that easy. When exporting to foreign countries, Chinese mask manufacturers must meet the standards of the destination country and have corresponding mask qualifications and certifications before they can be sold on the market.



                                       latest company news about Buda-U Face Mask Put into the White Lists By Both the USA FDA and the Chinese Ministry of Commerce Respectively.  0




In addition to the quality requirements of masks, the packaging requirements of various national standards are different and extremely strict.


For example, anti particulate respirators sold to EU countries must undergo strict testing and audit, or effective Model B + C2 CE certification before they can be put on the shelf on the market.


For disposable 3 layers masks, countries also have corresponding standards and requirements. Therefore, it has proved that it can be a big challenge for many Chinese manufacturers to get the relevant qualification documents.



Buda-U Protective Mask Respirator – Has Been Authorized as an EUA Model by USA FDA



PURIFA Medical Production Co., Ltd., located in Dalang, Dongguan, has its brand Buda-U. Due to the increasingly fierce competition in the mask industry recently, Buda-U brand attaches importance on not only to the foreign market, but also on the domestic market. It has also launched a series of adult and children's mask products in the domestic market.


The company's products have also been registered and certified by FDA. For export to the EU, Buda-U face mask respirator has obtained the EU CE certification in the early stage.


Recently, Buda-U folding mask product has been authorized as an EUA Model by the USA FDA. This has added another honor and credit to the Buda-U brand masks.


There are tens of thousands of mask manufacturers in China, and at present, there are only around 100 Chinese mask manufacturers that are qualified in this authorization.


Previously, Buda-U filtering half mask respirator entered the white list of the Ministry of Commerce, which means Buda-U Particulate respirator is one of the few enterprises that entered the "Double White List" of both the USA FDA and the Ministry of Commerce of China.



What exactly is "EUA" authorization?


The US Food and drug administration, namely Food and Drug Administration, is called FDA. Due to lack of masks in such severe COVID-19 pandemic. It has issued an Emergency Use Authorization for medical protective equipment products, namely The Emergency Use Authorization, or EUA.


According to Article 564 of the Federal Food, Drug and Cosmetic Act, FDA allows medical protection products authorized by EUA to be used by personnel involved in health and medical settings.


Obviously, Buda-U mask needs to be strictly reviewed and audited by FDA and goes through a series of procedures before Buda-U mask is put into the U.S.A EUA list.



The Competition of Mask Enterprises Has Become Far More Intense


At the beginning of this year, China started COVID-19, and the demand for mask was huge, but supply was scarce. Masks have also become "hard currency" for a time. With the promotion of market demand, domestic mask enterprises have been booming up, which soon made the domestic demand flooded.


With the spread of the epidemic in the world, the export of masks has become the choice of many enterprises. China has also quickly established its position as the world's leading manufacturing country for masks.



According to the data provided by China Customs, China exported more than 50 billion masks from March to May this year. With the surge in demand for masks for global epidemic prevention and the soaring price of masks, nearly 74000 companies in China registered as mask manufacturers in the first half of this year.


As an emerging industry, mask chaos also appears. Many enterprises have exposed the quality problems of masks. Subsequently, the Chinese government also strengthened quality supervision, requiring mask manufacturers to obtain the corresponding formal qualification of the destination country before they can export. Some low-quality mask enterprises have been squeezed out by the market.


In recent months, as the demand for masks decreases, the competition in the mask industry has become far more intense. Prices also returned to be normal. In the market environment where the original demand is far greater than the supply, the core of the competition for masks is the supplying ability of goods.


Now, the supply and demand of masks are also in a normal condition. The competition in the industry does not lie in the supply of goods, but in the comprehensive competition of product qualification, quality, market development and brand.


Under the severe situation of the global pandemic, the mask industry is still an opportunity and challenge for mask enterprises.



(Translation of the article publised on China.com ,18th, Sep.2020)


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