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WELL KLEAN® Medical Face Mask EN14683

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 



CodeRange LevelStyle
FMAL01TYPE I  (NON-STERILE)Earloop Mask
FMAL02TYPE II  (NON-STERILE)Earloop Mask
FMAL03TYPE IIR (NON-STERILE)Earloop Mask





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