Original Title: US Rejects Chinese Standard KN95 Mask, What's the Difference Between KN95 and N95? The global anti-epidemic situation is becoming more and more serious, and many countries have gone to China to "snap up" anti-epidemic supplies. However, in the case of the hot export of epidemic prevention materials, there are some discordant voices. German media reported that the Dutch Ministry of Health announced on the 28th the recall of hundreds of thousands of masks imported from China but distributed to medical institutions on the grounds that the quality of these Chinese masks was not up to standard. Spanish media reported that the Spanish Ministry of Health announced on the 26th that the country plans to return 9000 rapid detection kits imported from China because their detection sensitivity is not high enough. The continuous negative news has cast a shadow on the export of epidemic prevention materials. Only half a month after China's KN95, KP95 and other mask production standards were included in the approved list, the FDA of the United States updated the emergency use authorization of Non-NIOSH approved masks on March 28, deleting China's above-mentioned mask production standards from the approved list, which once again aroused market concern about the quality of export masks. The document refers to respirator products available in other countries, which were evaluated using methods similar to those used by NIOSH. China's KN95 masks are no longer approved for use in the United States, according to guidance issued by the US FDA. The guidelines exclude China from Non-NIOSH's list of countries. Masks made in China, including KN95, KP100, KN100 and KP95, will not be included in the EUA list. Two weeks ago, on March 17, the Centers for Disease Control and Prevention (CDC) announced the "Strategy for Optimizing the Supply of N95 Respirators: Crisis/Replacement Strategy",Medical Full Body Coverall
, which approved the replacement of N95 masks in other countries. The list includes Brazil, South Korea, Japan, Australia, Europe, Mexico and China (including four domestic mask models: KN100, KP100,Quickly Delivery Disposable Protective Clothing
, KN95, KP95), a total of seven countries and regions. Comparing the two notifications, China is the only one missing in the list of seven countries outside the United States to be recognized as a standard. Another overseas hospital official said that he had been contacting Chinese suppliers in the hope of obtaining medical supplies such as masks, but now it seems that this channel is being blocked by the FDA. According to the official website of the Occupational Safety and Health Administration of the United States, products without NIOSH certification are counterfeit products. Only NIOSH-certified respirators are allowed, the statement said. Is there any difference between KN95 and the N95 mask we hear about everyday? Can KN95 masks be used for first-line protection? Comparison and Analysis of Main Technical Indexes of Protective Mask Standard Expand the full text Photo Source: Jiangsu Market Regulation Professor Jin Z Xiangyu, deputy director of the Industrial Textiles Engineering Center of the Ministry of Education and director of the Department of Nonwovens and Engineering of Donghua University, said in an interview with the Economic Daily that N95 is the certification level of respirators in the United States and is certified by the National Institute of Occupational Safety and Health (NIOSH). This kind of mask can filter out more than 95% of non-oily particles (aerosols) under the condition of specified airflow (85L/min), so it is named N95. If it can filter more than 99% of particulate matter (aerosol), it is called N99 mask. In addition, corresponding to N95, KN95 Face Mask
,KN95 Face Mask with Five Layers
, KN95 is a mask certified by China's GB2626-2006 Respiratory Protective Equipment Self-priming Filter Particulate Respirator Standard. KN95 has the same level of protection as N95 mask, but it follows the test standards of different countries. KN95 masks follow Chinese standards and N95 mask follow American standards, both of which have a protective efficiency of no less than 95% against non-oily particles (sodium chloride particles for experiments). Jin Xiangyu introduced that KN95 masks and N95 mask include medical and non-medical types. Among them, KN95/N95 mask masks with "medical" logo can be used for first-line protection of medical staff during the anti-epidemic period, masks without "medical" logo are not recommended for medical staff, ordinary people can use them.
Masks conforming to GB19083 above Grade 1 can not only achieve 95% filtration, but also prevent liquid penetration, and can be used for various operations in medical institutions. According to Chinese Standard GB 2626-2006, the filtration efficiency of KN95 and KN100 tested with sodium chloride particles is ≥ 95% and ≥ 99.97% respectively, and the filtration efficiency of KP95 and KP100 tested with oil particles is ≥ 95% and ≥ 99.97% respectively. These standards are the same as those of the National Institute for Occupational Safety and Health (NIOSH). According to the FDA registered medical mask certification performance indicators provided by a testing agency, in addition to the particulate matter filtration efficiency indicators, hemodialysis indicators have been added. A person from a mask manufacturer pointed out to the media that there are requirements for synthetic blood penetration protection indicators for N95 medical masks in China to avoid patients'blood splashing on the masks, while there is no such requirement for KN95. But ordinary residents wear KN95, which is enough to meet the needs of COVID-19 prevention and control. Is the Chinese mask purchased by the Netherlands not qualified? China's response In response to the Dutch media's claim that the masks purchased from China were not up to standard, Chinese Foreign Ministry spokesperson Hua Chunying said at a regular press conference on April 2: "the masks were purchased by the Dutch agent himself, and the Chinese company had informed the Dutch side that the masks were non-medical masks before delivery." What are the differences between medical and non-medical masks? Jin Xiangyu disclosed that the external surface of medical masks has been treated with hydrophobic treatment. The surgical mask of GB19083-2010 and YY0469-2011 clearly put forward the requirements of "synthetic blood penetration" and the parameters of "surface moisture resistance", which clearly defined the protective effect of medical protective masks on blood, body fluids and other liquids. Generally speaking, just like a drop of water falling on a lotus leaf, the liquid cannot be soaked on the surface of the mask, which can block alcohol, blood and the like frequently touched by medical staff and prevent the rapid penetration of the alcohol and the blood; and a non-medical type KN95/N95 mask is not subjected to the special treatment. The filter layer of KN95 and N95 protective masks has the most protective function. The filter layer is made of polypropylene melt-blown superfine fiber electret material. The outer surface of the mask has not been hydrophobic treated. When it comes into contact with water and alcohol, the structure of the material will be destroyed and the filtering effect will be greatly reduced. Moreover, blood often contains bacteria, viruses and so on, and the application scenarios of hospitals determine that medical staff are likely to be exposed to the blood environment of patients. Therefore, hydrophobic treatment on the surface of medical masks is indispensable. Masks are divided into different protection standards and grades, as well as daily protection and professional medical protection. The Netherlands purchased non-medical masks at the time of purchase, so it does not meet the requirements of synthetic blood penetration protection indicators for medical protective masks. This incident may be a mistake, but it is also a wake-up call for mask manufacturers: once the epidemic prevention materials with poor quality are exported to foreign countries, they will not only face the risk of claims, but also damage the image of the country. Especially at this juncture of public opinion, any flaws may be magnified or even distorted. In an interview with the media, some insiders suggested that mask export enterprises should first measure whether the products can meet the relevant national standards, and more importantly, whether they can meet the quality standards of export areas. If they do not meet the standards, they should not donate or export as far as possible, because they can not provide effective quality reports, certificates and related documents. Otherwise, there will be endless trouble. This article is compiled from Economic Daily,Antivirus Disposable Mask with CE Certificate
, Cypress Blue, Jiangsu Market Supervision, Financial Magazine and CCTV Network. Return to Sohu to see more Responsible Editor:. zjyuan-group.com