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CE 0370 And FDA Disposable Nonwoven Face Mask Particulate Respirator , FFP2 Protective Respirator With Earloops

Categories Disposable Nonwoven Face Mask
Brand Name: Buda-U
Model Number: BU-E960-13
Certification: CE 0370 Certification
Place of Origin: Dongguan, China
MOQ: 20K
Payment Terms: T/T
Supply Ability: 500K Pcs Per Day
Delivery Time: To Be Advised Based on Quantity
Packaging Details: Single Pack or 5 Packs x 10 Pcs /Box, 50pcs / Box , 30 Boxes / Carton , 1500pcs /Carton
Product name: Nonwoven FFP2 Face Mask , FFP2 Particulate Respirator Mask, FFP2 Protective Respirator With Earloops ,CE 0370 and FDA
Color: White
Material: 5 Layers
Function: Filtering Half Mask Particulate Respirator
Style: Two Layers of Meltblown and Two Layers of Non Woven Fabric Plus One Layer of Hot Air Cotton
Type: Folded Mask
Class: FFP2 Protection Level
Feature: Premium Quality, Excellent Wearing Experience
Standard: EN 149:2001 + A1:2009
Size: Average code
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CE 0370 And FDA Disposable Nonwoven Face Mask Particulate Respirator , FFP2 Protective Respirator With Earloops

Nonwoven FFP2 Face Mask , FFP2 Particulate Respirator Mask, FFP2 Protective Respirator With Earloops ,CE 0370 and FDA


Key Specifications/Special Features:


  • • CE 0370, FDA;
  • • China Mask White List Exporter ;
  • • EUA Authorized Factory by USA FDA;
  • • Single Piece Pack or 10 Pcs Pack , 50 Pcs /Box, 1500 Pcs/Carton;
  • • Excellent Filtration efficiency against Non-Oil and Oil Particulates;
  • • Total 5 Layers;
  • •High Quality Packing Box with Internal and External Cover, Excellent Packing Design and Presentation;
  • •Packing Box and Polybag with Different Global EAN Barcodes,
  • •MFG Date , EXP. Date & LOT No. Actively Printed on Packing Box ;

Packing Specifications:


  • Option A:

Single pack, 50pcs / Box

30 Boxes / Carton , 1500pcs /Carton

【Box】15.5cmX12cmX20cm

【Carton 】62cm X 48.5cm X 42cm

【NW】around 12KG/carton

【GW】around 13KG/Caron

【Container】

40 Feet HQ loads 515 cartons = 772500 Pcs


  • Option B:

10 Pcs / Pack , 5 Packs x 10 Pcs /Box, 50pcs / Box

30 Boxes / Carton , 1500pcs /Carton

【Box】14 cmX12cmX 17.5 cm

【Carton 】62cm X 44cm X 37cm

【NW】around 10KG/carton

【GW】around 11KG/Caron

【Container】40 Feet HQ loads 679 Cartons = 1018500 Pcs


Competitive Advantage:


≥94% Filtration efficiency against Non-Oil and Oil Particulates; In conformity with FFP2 NR under EU Standard;


High Quality Packing Box with Double Cover, Meeting All Requirements of EN 149:2001+ A1 :2009, FFP2


Manufacturing Date and Expiration Date are Actively Printed on the Box; Latex-Free;High Breathability ;Skin Friendly Materials;


Specially Designed Shape and Ultra-Comfort Materials; Elastic and Firm Earloops;


Two Layers of Meltblown Fabric 50pcs / Box , 1500 Pcs /Carton


Optional Packing : Single Pack , Customized Packing Language,Global EAN Bar Code on Packing Box


Certifications and Qualifications:


CE 0370 Module B Certificate – 1of 2 CE 0370 Module B Certificate - 2 of 2

CE 0370 Module B Certificate - 1/2 of 2


CE 0370 Module C2 Certificate – 1of 2 CE 0370 Module C2 Certificate - 2 of 2

CE 0370 Module C2 Certificate - 1/2 of 2


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 :


According to European Standard, EN 14683:2019 +AC : 2019, Medical face masks specified in this European Standard are classified into two types (Type I and Type II) according to bacterial filtration efficiency whereby Type II is further divided according to whether or not the mask is splash resistant. The 'R' signifies splash resistance.


Type I : Bacterial filtration efficiency (BFE) ≥ 95

Type II: Bacterial filtration efficiency (BFE) ≥ 98

Type IIR: Bacterial filtration efficiency (BFE) ≥ 98, with splash resistance.


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)


Test

Type I aType II

Type 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:

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