[Product model]: flat (ear hook)
[We have certifications]: FDA/CE
[Scope of application]: it is suitable for the user to wear it during non-invasive operation, covering user’s mouth, nose and jaw, providing a certain physical barrier to prevent the direct penetration of microorganisms and particles.
[Method of use]:
1. Check whether the package is in good condition before use, and confirm the expiry date of the product;
2. Open the package and take out the mask. The upper part of the nose clip is with the color face facing out.press the nose clip to minimize the gap between the face and the mask;
3. Avoid touching the mask when using. After touching the used mask, wash hands with cleaning and disinfection supplies;
4. Change into a new clean and dry mask after the mask is damp.
[Period of validity]: two years
[Authentication level]: II
[Executive standard]:YY 0469-2011
Medical surgical disinfection mask, through liquid barrier test, can prevent the patients from being infected by the virus of medical staff, and sterilized for 14 days.
According to performance characteristics and scope of application, medical masks can be divided into: medical protective masks, medical surgical masks, ordinary medical masks.1. Medical protective mask
Medical protective masks are suitable for the protection of airborne respiratory tract infectious diseases by medical staff and related staff. It is a close-fitting self-priming filter medical protection article with a high protection level, especially suitable for contact with airborne transmission during diagnosis and treatment activities. Or worn by patients with respiratory infections transmitted by droplets at close range. It can filter the particles in the air, block droplets, blood, body fluids, secretion droplets, etc. It is a disposable product. Medical protective masks can prevent most pathogens such as bacteria and viruses. WHO recommends medical personnel to use protective masks against particles to prevent viral infections in hospital air.
Medical protective masks comply with GB19083-2003 “Technical Requirements for Medical Protective Masks”. Important technical indicators include non-oily particle filtration efficiency and airflow resistance. The specific indicators are as follows:
1) Filtration efficiency: Under the condition of air flow (85 ± 2) L / min, the filtration efficiency of aerodynamic median diameter (0.24 ± 0.06) μm sodium chloride aerosol is not less than 95%, which is in accordance with N95 ( Or FFP2) and above. It can block infectious agents with a diameter of less than 5 μm transmitted by air or close contact with infectious agents transmitted by droplets.
2) Inhalation resistance: under the above flow conditions, the inhalation resistance does not exceed 343.2Pa (35mmH2O).
3) For the samples sprayed on the mask under the pressure of 10.9Kpa (80mmHg), no technical indicators such as penetration should appear on the inside of the mask.
4) The nose mask must be equipped with a nose clip, which is made of bendable plastic material and has a length> 8.5cm.
5) Synthetic blood is sprayed towards the mask sample at a pressure of 10.7kPa (80mmHg), there should be no penetration inside the mask.
2. Medical surgical mask
Medical surgical masks are suitable for the basic protection of medical staff or related personnel, as well as the protection against the spread of blood, body fluids and splashes during the invasive operation. The protection level is medium and has certain respiratory protection performance. It is mainly used in clean environments with a cleanliness level of less than 100,000, operating in the operating room, nursing patients with low immune function and performing body cavity puncture and other operations. Medical surgical masks can block most bacteria and some viruses, can prevent medical staff from being infected, and can also prevent the microorganisms carried by medical staff’s breath from being directly discharged, posing a threat to patients undergoing surgery. Medical surgical masks require the filtration efficiency of bacteria to be above 95%. Disposable medical surgical masks should also be issued to suspicious respiratory patients to prevent the threat of infection to other hospital personnel and reduce the risk of cross-infection, but to avoid infections that are less effective than medical protective masks.
It complies with YY0469-2004 “Technical Requirements for Medical Surgical Masks”, and important technical indicators include filtration efficiency, bacterial filtration efficiency and respiratory resistance. The specific indicators are as follows:
1) Filtration efficiency: Under the condition of air flow (30 ± 2) L / min, the filtration efficiency of aerodynamic median diameter (0.24 ± 0.06) μm sodium chloride aerosol is not less than 30%.
2) Bacterial filtration efficiency: under specified conditions, the filtration efficiency of Staphylococcus aureus aerosol with an average particle diameter of (3 ± 0.3) μm is not less than 95%; bacterial filtration rate should be ≥95%; non-oily particles The filtration rate should be ≥30%.
3) Breathing resistance: Under the condition of filtration efficiency flow, the inhalation resistance does not exceed 49Pa, and the exhalation resistance does not exceed 29.4Pa. When the pressure difference △ P of gas exchange on both sides of the mask is 49Pa / cm, the gas flow rate should be ≥ 264mm / s.
4) Nose clips and mask straps: Nose clips should be provided on the mask. The nose clips are made of plastic materials and the length of the nose clip should be greater than 8.0cm. The mask band should be easy to wear and take, and the breaking strength at the connection point between each mask band and the mask body should be greater than 10N.
5) Synthetic blood penetration: After 2ml of synthetic blood is sprayed at the pressure of 16.0kPa (120mmHg) towards the outer side of the mask, no penetration should occur on the inner side of the mask.
6) Flame retardant performance: The mask material should be made of non-flammable materials, and the mask burns less than 5s after leaving the flame.
7) Residual amount of ethylene oxide: For masks sterilized by ethylene oxide, the residual amount of ethylene oxide should be less than 10μg / g.
8) Skin irritation: The primary irritation index of the mask material should be ≤0.4, and there should be no sensitization reaction.
9) Microbial indicators: total bacterial colonies ≤20CFU / g, and no coliform bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococci and fungi shall be detected.
3. Ordinary medical mask
Ordinary medical masks are used to block spouts exhaled from the oral cavity and nasal cavity, and can be used for one-time hygiene care in ordinary medical environments with the lowest protection level. It is suitable for general hygiene care activities, such as sanitary cleaning, liquid distribution, cleaning bed units, etc., or the blocking or protection of particles other than pathogenic microorganisms such as pollen.
Conforms to the relevant registered product standard (YZB), generally lacks the filtration efficiency requirements for particles and bacteria, or the filtration efficiency requirements for particles and bacteria are lower than medical surgical masks and medical protective masks, only reaching 20.0% for 0.3μm diameter aerosols -25.0% protection effect, can not reach the filtration efficiency of particles and bacteria, can not effectively prevent pathogens from invading through the respiratory tract, can not be used for clinical invasive operations, nor can it protect particles and bacteria and viruses, only limited to dust particles Or aerosol plays a certain mechanical barrier.