Intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Size: | 17.5X9.5CM |
Materials: | SPP NONWOVEN+MELTBLOWN |
Pack: | 50PCS/BOX,40BOXES/CASE |
Color: | White,blue,Green, |
Code: | FMAL |
Product Information
Key Features : This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations vice;versa) during surgical procedures in operating theatres and other medica settings with similar requirements. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. This standard is intended to help facilitate the choice of surgical face masks in the European Market by standardizing the information and performance data required for the masks.
Spp Nonwoven+melt-blown fabric weight 25/25/25 gsm
Standard under EN 14683:2019
Bacterial Filtration Efficiency
Differential Pressure
Splash Resistance Pressure
Microbial Cleanliness(Limit 30cfu/g)
TYPE I BFE 95% Less than 40PA/cm2
TYPE II BFE 98% Less than 40PA/cm2
TYPE IIR BFE 98% Less than 60PA/cm2 Above 16kPA
Material Composition
• Face masks are 3-ply protection, ear loop, easy breathable
• Soft, lightweight, comfy and easy to wear
• Soft, lightweight and easy to wear
• Protective splash face shield.
• Double side anti-fog, anti-static, no-glare lens.
• Available in both elastic band and adjustable Velcro band.
• Lightweight and comfortable to wear, quick and easy to don.
Country of Origin
Made in China
Use For
• Intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
• Always follow User Instructions and use in manners as indicated
Do Not Use For
• DO NOT use in industrial settings
• DO NOT use for gases or vapors (i.e. anesthetic gases such as isoflurane or vapors from sterilants such as glutaraldehyde.)
• DO NOT use in any manner not indicated in the User Instructions Approvals and Standards
• Assigned Protection Factor (APF 10) per US OSHA and Canada CSA
Time Use Limitation
Respirator may be used until damaged, breathing becomes difficult or contaminated with blood or body fluids. Discard after every use when used for surgical procedures. Follow national, state, local, and facility infection control guidance and policies.
Shelf Life and Storage
• 2 years from the date of manufacture
• Use By date on box in YYYY-MM-DD format
• Store respirators in the original packaging, away from contaminated areas, dust, sunlight, extreme temperatures, excessive moisture, and damaging chemicals
Code | Range Level | Style |
FMAL01 | TYPE I (NON-STERILE) | Earloop Mask |
FMAL02 | TYPE II (NON-STERILE) | Earloop Mask |
FMAL03 | TYPE IIR (NON-STERILE) | Earloop Mask |