Myflon ASTM Level 3 Surgical Mask, FDA 510(k) K212111

FDA 510(k) cleared - K212111

MYFLON Surgical Masks

A surgical mask is a mask that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks intended for medical purposes are considered medical devices. The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests. Surgical masks are also tested for biocompatibility and are considered personal protective equipment (PPE). While a surgical mask may be effective in blocking splashes and large-particle droplets, they do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.

Myflon products are certified with ISO 9001, ISO 13485, EN13795 and CE marking.

Myflon Surgical Mask LEVEL 3 is now FDA 510(k) cleared. FDA 510K clearance ensures additional safety and higher quality regulation to our products.

ASTM Level 3 surgical masks manufactured by Myflon recently received 510(k) clearance from the US Food and Drug Administration (FDA). The surgical masks are intended for use by healthcare personnel to protect both the patient and themselves from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.

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,"

SURGICAL MASK - LEVEL 2/ Level 3

Medical masks are worn by operating room personnel during surgical procedures. They protect both the patient and operating room staff from the transfer of:

• bodily fluids
• micro-organisms
• particulate material

There are 3 classifications under ASTM International standards:

• Level 1 (low) - venous pressure splash
• Level 2 (moderate) - arterial pressure splash
• Level 3 (high) - high-velocity procedures, orthopedic surgery

Surgical Masks- ASTM F 2100 - LEVEL 1 , LEVEL 2, LEVEL 3

• Bacterial Filtration Efficiency
• Differential Pressure for breathability
• Synthetic Blood Penetration for Face Masks
• Microbial Cleanliness for Face Masks
• Cytotoxicity, Sensitization , Irritation
• EN 14683 Type IIR
• EN 14683 Type II
• EN 14683: 2019 +AC : 2019 ( TS EN 14683+AC:2019) EK-B
• EN ISO 11737-1:2018 / TS EN ISO 11737-1 : 2018

Mask, nonwoven mask, surgical mask, surgical masks, en 14683 masks, protective masks

Mask with soft elastic ears

allergy free

latex free

paraben free

Nylon free

Klor free

EN 14683 Type II

ISO 13485

Read our buying guide: What FDA 510(k) Clearance Means for Surgical Masks and Gowns