What qualifications are required for the production of medical masks?

According to the "Notice on the Classification of Medical Disposable Medical Surgical Masks and Other Products" issued by the Food and Drug Administration, medical surgical masks are classified as Class II medical devices. The production of medical surgical masks requires a medical device production license. Class medical device business record. Medical masks include: medical protective masks, medical surgical masks, and general medical masks, while ordinary cotton gauze masks, sponge masks, and activated carbon masks on the market are not in the queue of medical masks. For the identification standards of medical masks, you can refer to the national standard GB19083-2010 "Technical Requirements for Medical Protective Masks", industry standard YY0469-2011 "Technical Requirements for Medical Surgical Masks" and YY/T0969-2013 "Technical Requirements for Disposable Medical Masks" ", if it does not meet the above standards, it can be regarded as an unqualified mask that does not have protective and rescue functions.

Detailed introduction:

1. GB 19083-2010 Technical requirements for medical protective masks

At present, the mandatory medical standard in medical mask testing, masks that meet the requirements of this standard can be used in medical work environments to filter particulate matter in the air, block droplets, blood, body fluids, secretions, etc. In addition to the basic index requirements of medical masks, this type of mask can also meet the filtration efficiency of non-oily particulate matter greater than or equal to 95%. It is recommended to be worn by medical staff in fever clinics, isolation wards, and confirmed patients when transferring.

2. YY/T 0969-2013 Disposable medical masks

Recommended industry standard for mask testing, suitable for disposable masks that cover the user's mouth, nose and jaw, and are used in ordinary medical environments to block the exhalation or exhalation of pollutants from the oral and nasal cavities.

3.YY 0469-2011 Medical surgical masks

Mandatory mask testing industry standard, masks that meet the requirements of this standard can be worn by clinical medical staff during invasive operations, etc., have the effect of preventing blood penetration, and the protective effect is better than disposable medical masks.

4. GB/T 32610-2016 Technical Specifications for Daily Protective Masks

Masks that meet the requirements of this standard can be used to filter out particles with a particle size of less than or equal to 2.5 microns in air pollution environments in daily life. 5.GB 2626-2019 Respiratory protection

Self-priming filtering anti-particulate respirator

Self-priming filter respiratory protective equipment suitable for protection against various types of particulate matter.

3R Medical receive FDA 510(k)

Introduction of medical protective clothing