Myflon Surgical Mask LEVEL 3 is now FDA 510K approved. we are honored to be Turkey`s first FDA 510K cleared surgical mask brand. FDA 510K clearance ensures additional safety and higher quality regulation to our products.
For the US market, Myflon is now providing FDA 510K cleared surgical masks meeting the Level 3 standard of the American Society of Testing and Materials (ASTM). The ASTM Level 3 surgical mask is for use in conditions where there is a high risk of fluid and spray of aerosol transmission, such as operating procedures. The masks are a single use, disposable device provided non-sterile.
Surgical masks by Myflon were tested for performance in five areas: fluid resistance, differential pressure, particulate efficiency, bacterial filtration efficiency and flammability. Upon completion of testing, the surgical masks consistently met ASTM Level 3 criteria in all five performance test areas. Bacterial and particle filtration efficiency test results were greater than 99 percent.
“This was a great accomplishment for our team. It is a milestone that supports our commitment to continue manufacturing high performance products. Meeting the ASTM Level 3 standard helps us in our goal to not only keep our healthcare workers safe, but also ensure they have a steady, reliable PPE supply so the shortages that happened at the beginning of the pandemic don’t happen again,”
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Surgical masks are widely used for two main purposes.
The first is the use of healthcare professionals to protect patients in the hospital setting. The immune system of the patient in the operating room or intensive care unit is low. Any germ that can be taken from the outside can even lead the patient to death. For this reason, it is used to prevent the spread of infection by people other than the patient in order to prevent infection from people in contact with the patient. For this reason, the surgical mask is considered as a medical device and is evaluated within the scope of the Medical Device Regulation. Surgical masks are produced within the scope of the Medical Device Regulation, meeting the conditions deemed necessary by the Ministry of Health.
The second is the general use during epidemic periods to prevent the spread of the disease and to protect people from the epidemic. The purpose of this use; It is the prevention of viruses and germs that may be present in the user while breathing, from passing to the outside environment through the filter mask. In other words, the main purpose of using surgical masks is not to protect us from our environment, but to protect our environment from us. The secondary purpose is to protect the person using the mask from viruses and germs. Depending on the filtration properties of the mask used and the quality and thickness of the fabric used, the protection of the person may be at a high level.
Scientifically called medical face mask. In general usage, it is also known as face mask, medical mask, surgical mask, medical mask. Although they are recommended for the use of the whole society during epidemic periods, they are products that provide filtering used especially by health professionals in other periods. It is produced to prevent the spread of the disease with its filtered structure and to protect the user from the disease. It can be used to filter pollen, dust particles and harmful particles, as well as filtering highly contagious microorganisms such as bacteria, viruses, fungi.
They are produced from nonwoven mask fabrics, which are generally referred to as non-woven/non-woven. They provide particle and bacteria filtration with their non-porous structure. In the test standard, tests are carried out with particles simulating various microorganisms, and the products that successfully pass these tests are classified according to the filtering level and offered for use.
It is possible to evaluate the products in two ways as sterile and non-sterile. Sterile masks are mostly used to protect patients in contact with patients with compromised immune systems. The definition of sterile mask is used for products where the product is sterilized and does not contain germs. In sterile masks, it is mandatory to test the product by accredited institutions.
The non-sterile mask is suitable for daily use. Again, the product is produced by providing hygiene conditions, some products can even be sterilized. But it is aimed at daily use, not operating rooms. In non-sterile masks, it is not mandatory to test the product by accredited institutions, but many companies want to prove the reliability of the product with a test report.
In normal use, according to the advice of experts, a mask wearing time of 3-4 hours is foreseen. It is recommended to replace it with a new one afterwards. However, contrary to the situation stated in the instructions for use of the product, if there is a use and/or damage situation, it is necessary not to use the product. The filtering effect is reduced or completely destroyed when the product is wet, damp, torn and deteriorated. For this reason, when such a situation is encountered, it should be replaced with a new one. Surgical masks have a shelf life of 3-5 years, which varies from product to product. Products should be used in accordance with their shelf life.
While researching quality masks and good masks, it is necessary to conduct a detailed examination under 4 headings:
test report of the product
company`s quality infrastructure and quality documents
functions of the product
proving the functions of the product.
Surgical masks are tested by the TS EN 14683 standard published by the Turkish Standards Institute (TSE). When looking for a quality surgical mask, first of all, it is necessary to look at whether the product has been tested by an accredited testing institution, and then the test results. If the test institution is accredited by the Turkish Accreditation Agency (TÜRKAK) and/or internationally respected authorities, the test report is reliable. The product can be preferred if the test report results also provide good filtration, if the microbial cleanliness is sufficient and if the breathability standard is met.
The product must be registered in the Ministry of Health Product Tracking System (ÜTS). The use of UTS registered products is important in order not to encounter negative products. Since the medical mask is produced within the scope of the Medical Device Regulation, it is important that the production facility has ISO 9001 Quality Management System and ISO 13485 Medical Devices Quality Management System. The company has this infrastructure accredited by TURKAK and/or internationally respected authorities.
The fact that the product is successful in test reports is not enough for it to be a reliable mask. At the same time, the facility where the product is produced must provide the necessary conditions such as production, hygiene, storage, periodic inspection mechanism for the production of medical devices. This is very important to maintain consistent quality and prevent any errors before they occur. Along with these quality systems, the fact that the company has Good Manufacturing Practices (GMP), is registered with the FDA (American Food and Drug Administration), has TSE COVID-19 Safe Production Certificate, and has quality and continuity-enhancing documents such as: increases confidence.
It is useful to look at the characteristics of the product after the confidence that the product and its production are made in accordance with medical devices.
The higher the filtering structure of the product, the higher its protection. For this reason, the use of products with high protection minimizes the risks.
In addition, the medical mask should completely cover the face and should not create any openings.
It is important that the product has a 3-layer structure. Generally, 3-ply masks are produced using spunbond mask fabric and meltblown mask fabric. Products with spunbond (3S) in all 3 layers generally provide less protection than SMS mask (spunbond-meltblow-spunbond) products with meltblown fabric in the middle layer. Using a meltblown filter mask increases protection.
The weight of the fabric used per square meter is also important. Dense fabric provides higher protection.
But the greater the protection, the harder it is to breathe. For this reason, it is important to use products with high breathability and successfully passed the tests in this field.
In mask products with nose wire, the wire can be easily shaped and should not open on its own.
Ear rubbers should not cause discomfort in long-term use and the product should be designed to fit the face perfectly. Elastic ear products provide an advantage in this regard.
Since the threads in ultrasonic mask products are adhered not by sewing but by pressure and sound, thread formation is not observed, providing comfort in use.
The product is produced for protection, but it should be ergonomic and in a structure that protects human health in use.
In order to be an antibacterial mask, it is sufficient that the innermost layer of the product is antibacterial. Antibacterial structure is important for health in long-term use.
The layers and other parts used in the product are anti-allergic masks are called anti-allergic masks. This type of masks prevent allergy problems in use.
However, the paint and painting technique used in colored mask and patterned mask products is important. These products, which are in direct contact with the skin and are respirable, must be produced with raw materials suitable for human health. Otherwise, it poses great risks to health.
It is also very important that the products are hygienic. The use of hygienic masks that are produced without human touch or that provide hygiene with methods such as UV-C rays during the packaging stage should be preferred. Considering that they are used for health purposes and are suitable for breathing, it is important that the product reaches the end user in a hygienic way. The products packed in the machine without human touch give confidence.
In addition to the medical mask tests, it is important that the product passes the germ-free tests, tests that show that it does not contain harmful dyes, and allergen tests.
These should be considered when choosing a product.
There are 3 mask types as protection level:
Type I mask
Type II mask
Type IIR mask
Type I defines products that provide 95% and above filtration for general public use.
Type II provides better filtration with filtration of 98% and above. Type II is generally recommended for healthcare professionals, but it is also recommended for public use in crowded and confined environments.
Type IIR provides better filtration with filtration of 98% and above. Type IIR type masks, on the other hand, provide extra protection thanks to their water-proof feature against droplets suspended in the air, sneezing and blood splashes, as well as being filtered. Type IIR is suitable for use by doctors, nurses, surgeons and other health professionals in areas where there is intense contact with the patient, such as operating rooms. Type IIR can also be used by the public in crowded and high-risk areas where you may have contact with the patient.