September 26, 2021

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Chinese Medical Masks with certificates

Chinese Medical Mask with certificates

CCCMHPIE ( China Chamber of Commerce for Import and Export of Medicines and Health Products ) updated the list on April 26 2021, which lists Chinese Medical Mask with certificates and related 2,673 manufacturers that have obtained the certificate issued by other countries.

20210426 Medical Masks

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What’s Medical masks? What the difference between Medical and Non-Medical Masks?

 

Medical Class Masks

 

Medical masks

Contains: medical protective masks, medical surgical masks, medical disposable masks

 

Non-medical mask

Including: self-priming filter anti-particulate respirator, daily protective mask, etc.

 

Comparison of Medical Mask and Non-medical Mask:

 

Medical masks

Medical masks are mostly made of one or more layers of non-woven fabrics. The main production processes include meltblown, spunbond, hot air or needle punching, etc., which are equivalent to resist liquids, filter particles and bacteria. A medical mask is composed of a mask face and a tensioning belt. The face of the mask is divided into three layers: inner, middle and outer. Fiber meltblown material layer), the outer layer is a special material antibacterial layer (non-woven fabric or ultra-thin polypropylene meltblown material layer).

 

Non-medical mask

1 ) Self-priming filter type particulate respirator, also known as “dust mask”, “dust mask”, “dust mask”, etc., is mainly used to protect against particulate pollutants such as dust, smoke, fog, etc., and is used by the body’s own breathing Respiratory protection products are widely used in industrial production and daily life. Common N95 masks belong to this type of product. N95 is the protection level in the American standard, which is equivalent to the KN95 protection level in the Chinese national standard GB 2626.

Self-priming filter anti-particulate respirators are classified into disposable masks, replaceable half-masks and full-face masks according to the mask structure. Disposable masks are the most widely used. Most of them use two layers of non-woven fabric inside and outside, and one in the middle. Layer filter cloth (melt blown cloth) is constructed.

Due to the different workplaces, the particles that people come into contact with are generally divided into two categories: non-oily and oily. Non-oily particles such as dust, water-based mist, paint mist, non-oily fume (welding fume), microorganisms, etc., oily particles such as Oil mist, lampblack, asphalt smoke, coke oven smoke, etc. The masks used to protect against non-oily particles are “KN” type masks, and the masks for oily particles are “KP” type masks. Different dust masks use different filter materials, and filter materials suitable for oily particles can also be used for non-oily particles. Ordinary citizens mainly use “KN” masks.

The product standard of this type of mask is GB 2626-2006 “Respiratory Protective Equipment Self-priming Filter Type Anti-Particulate Respirator” (the new standard will be implemented after July 1, 2020, the standard number is GB 2626-2019).

2) Daily protective masks refer to masks worn to filter out particulate matter in daily air pollution environments. The protection objects include PM2.5, PM10, pollen, etc. The product standard is GB/T 32610-2016 “Technical Specification for Daily Protective Masks”.

The protective effect of daily protective masks is divided into A, B, C, and D from high to low. According to the degree of air pollution, they are respectively suitable for severe pollution, severe pollution and below, heavy pollution and below, moderate and below Pollution and other atmospheric environment.

 

Main technical requirements difference

The application fields of medical masks and non-medical masks are different, resulting in different technical indicators and technical requirements.

 

01 Comparison of main technical requirements for medical masks

Among the three kinds of medical masks, medical protective masks have the most complete protection functions. The technical requirements include: bacterial filtration efficiency, filtration efficiency (non-oily particles), inhalation resistance, synthetic blood penetration, surface moisture resistance, microbial indicators, etc.; one-time use Medical masks have the least protective functions. The technical requirements include: bacterial filtration efficiency, ventilation resistance, microbial indicators, etc.; medical surgical masks are somewhere in between. The technical requirements include: bacterial filtration efficiency, filtration efficiency (for non-oily particles), and masks. Lateral pressure difference, microbial indicators, synthetic blood penetration, etc.

Medical protective masks and medical surgical masks both include filtration efficiency indicators for non-oily particles and synthetic blood penetration indicators. The filtration efficiency index of the former (≥95%) is higher than the latter (≥30%), but synthetic The blood penetration index (anti-10.7kPa synthetic blood pressure) is lower than the latter (anti-16.0kPa synthetic blood pressure).

 

02 Comparison of main technical requirements for non-medical masks

The technical requirements of the self-priming filter anti-particulate respirator and the daily protective mask are relatively close. Compared with the latter, the former does not contain indicators such as microorganisms, formaldehyde, pH value, and color fastness to rubbing, but the former is in the process of filtering efficiency testing The simulated particulate matter environment is worse than the latter.

 

03 Comparison of main technical requirements for medical masks and non-medical masks

1). Medical masks are mainly used in the medical working environment to filter particles in the air and block droplets, blood, body fluids, secretions, etc. Therefore, medical masks are more focused on the protection requirements of medical and health masks, such as resistance to synthetic blood penetration, moisture resistance, biological evaluation, etc., so as to ensure that the mask has the characteristics and functions of hygiene and prevention of blood/body fluid splashing. These technical requirements are not available in non-medical masks.

2). Medical masks are not allowed to have an exhalation valve. For example, clause 4.3 of GB 19803-2010 clearly stipulates that “masks should not have an exhalation valve”, so as to prevent droplets and microorganisms from exhaling through the exhalation valve, thereby harming others. Non-medical masks are allowed to have an exhalation valve, and the exhalation resistance can be reduced through the exhalation valve, which is conducive to the long-term work of the operator. The standard has the technical index of the air tightness of the exhalation valve.

3). The particulate matter protected by medical mask standards GB 19083-2010 and YY 0469-2011 is non-oily particulate matter, while the particulate matter protected by non-medical mask standards GB 2626-2006 and GB/T 32610-2016 includes non-oily particulate matter. , Including oily particles.

4). Non-medical masks are mainly used for industrial dust protection and atmospheric pollutant/smog protection. Compared with the medical and health environment, the particle concentration of protection is higher. In terms of the most important technical indicators of particle filtration efficiency, the test methods of GB 19083-2010, GB 2626-2006, and GB/T 32610-2016 are not completely the same. GB 19083-2010 only needs to test the initial filtration efficiency, GB 2626-2006 In addition to the initial filtration efficiency of GB/T 32610-2016, it is also necessary to test the filtration efficiency after the accumulation of particulate matter. That is to say, the test environment of GB 2626-2006 and GB/T 32610-2016 simulates the harsh working environment and the haze environment respectively. Therefore, the filtration efficiency is also 95%, and it cannot be said that the filtration capabilities of the three standard mask filter materials are exactly the same.

 

 

 

Two types of mask management system: 

 

01) Medical mask

According to the “Medical Device Classification Catalogue”, the management category of medical masks is classified as Class II. According to the Regulations on the Supervision and Administration of Medical Devices, “Class I medical devices are subject to product registration management, and Class II and Class III medical devices are subject to product registration management. “. It is required that enterprises engaged in the production of Class II and Class III medical devices shall apply to the food and drug regulatory department of the people’s government of the province, autonomous region, or municipality where they are located for a production license. For those that meet the prescribed conditions, the license is granted and a medical device production license is issued. Before production and operation can be carried out.

 

02) Non-medical masks

The self-priming filter-type anti-particulate respirator in non-medical masks is a respiratory product in the “special labor protection equipment”. Before September 2019, the “special labor protection equipment” shall implement the management of industrial product production licenses. After the “Decision of the State Council on Adjusting the Catalogue of Industrial Product Production License Management and Strengthening Interim and Ex-post Supervision” (Guo Fa [2019] No. 19), the management of industrial product production licenses has been cancelled for this type of products. At present, quality supervision is mainly based on supervision and spot checks. Mainly.