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3 Layers Surgical Nonwoven Face Mask , Protective Face Mask With Earloops , FDA CE Certification

PURIFA Medical Production Co.,Ltd

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3 Layers Surgical Nonwoven Face Mask , Protective Face Mask With Earloops , FDA CE Certification

Country/Region china
City & Province dongguan guangdong
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Product Details

 Surgical Nonwoven Face Mask, Protective Face Mask, 3 Layers Mask with Earloops, FDA and CE  

 

 

  • • BFE ≥98% , Non-Sterile, TYPE IIR Level ;
  • • CE Certification, FDA Device Listed.
  • • In conformity with EU Standard: EN 14683: 2019 + AC:2019
  • • 3 Layers , with Meltblown Fabric in the middle. 
  • • Resistant to Fluid/Blood Penetration;
  • • Good Breathability.
  • •  Firm, Elastic & Comfortable Earloops ;
  • •  EC REP Information Printed on Packing Box .

Packing Specifications:

 

• Packed with Easy-to-draw Polybag in High quality Box

• 50 Pcs /Box , 2500Pcs / Carton, LWH: 52CM X 42CM X 42CM

 

Competitive Advantage:

 

      

BFE ≥ 98% or Above Filtration Efficiency;      In conformity with EU Standard;

 

      

Easy-To-Draw Polybag, High Quality Packing Box;       50 Pcs / Box

 

      

Manufacturing Date and Expiration Date, EC REP Printed on the Box; High Breathability ;

 

       

 

     

      

 

Certifications and Qualifications:

 

 

CE 0370 Module C2 Certificate - 2 of 2

Meeting All Requirements of EN 14683: 2019 + AC:2019; DOC

 

China CCCMHPIE White List

China CCCMHPIE White List

 

 

Frequently Asked Questions :

 

Question: 

 

We have Heard Quite Much About Type I, Type II, and Type IIR Face Mask. What Are Exactly Type I , Type II, Type IIR About ?

 

Answer: 

 

 

 

The following Table can indicate clearly on the performance requirements of  Type I, Type II and Type IIR. Type II can be used  for medical settings, Type IIR Face Masks are used as surgical environments since it's Splash resistance has mandatory requirements. 

 

 

                               Table  — Performance Requirements For Medical Face Masks (EN 14683:2019 +AC:2019)

 

TestType I aType IIType IIR
Bacterial filtration efficiency (BFE), (%)≥ 95≥ 98≥ 98

Differential pressure

(Pa/cm2)

 

< 40

 

< 40

 

< 60

Splash resistance pressure (kPa)Not requiredNot required≥ 16.0
Microbial cleanliness (cfu/g)≤ 30≤ 30≤ 30
a Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements.

 

 

 

 

To Get More Information About the EU Medical Face Masks Standard

Download EU Medical Face Masks Standard : EN 14683 : 2019 + AC : 2019

 


DOWNLOAD

 

 

 

 

Tag:

Face Mask, Disposable Face Mask,disposable mask ,3PLY mask,3ply face mask,Medical Face Mask,Medical mask, Dust mask,EN14683 Mask,Medical device, ASTM Face Mask, ASTM Surgical Mask

 

 

 

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