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

Brand Name:Buda-U
Certification:CE, FDA
Model Number:BU-E50B-7
Minimum Order Quantity:50K
Delivery Time:To Be Advised Based on Quantity
Payment Terms:T/T, FOB, EX-FACTORY
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Location: Dongguan Guangdong China
Address: No.128, Langchang Rd., DaLang, Dongguan, Guangdong, P.R. China.
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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:


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


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

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

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

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