Disposable Non-Woven En14683 Type Iir Surgical Mask

• Customization: Available
• Type: Face Mask/Apron/Gloves
• Material: Non-Woven Fabric, Nonwoven Fabric
• Model NO.: WELLMIEN-FM008
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: Three Years
• Group: Adult
• Logo Printing: With Logo Printing
• Style: Earloop or Tie on
• Composition: Latex Free and Fiberglass Free
• Color: Blue, Pink, White, Green
• Size: 17.5*9.5cm
• Transport Package: 50PCS/Box, 40boxes/Carton
• Specification: CE/ISO13485
• Trademark: WELLMIEN OR OEM
• Origin: Jiangsu
• HS Code: 6307900090
• Production Capacity: 60, 000, 000pcs per month

Product Description

HOT PRODUCT

Disposable Non-Woven EN14683 Type IIR Surgical Mask

 

Style	earloop
Size	17.5*9.5cm
Material	3ply: SBPP,MB,SBPP
Certification	FDA 510K, CE, ISO13485
Structure	without face visor
Type	without soft foam
Nose clip	double wire

 

Specification:

1.Conform to FDA 510K (No:K101000).

2. Glass fiber-free and latex-free.

3. Breathing Resistance (Delta P)<6.0.<>

4.Bacterial Filtration Efficiency (BFE%) >99%

5.Particle Filtration Efficiency(PFE%)>99%.

6. Synthetic Blood Penetration Resistance: 160mmHg.
 

Packing:

Normal Packing	QTY (pc)	Carton Size (cm)	N.G (kg/ctn)	W.G (kg/ctn)	Prodution Time (day)
50pcs/box 40boxes/ctn	200,000	52X40X36	7.5	8.5	10
	700,000 (1X20GP)				15
	1,440,000 (1X40GP)				20
	1,720,000 (1X40HQ)				20
Remark: Production time is based on quantity and the time of order confirmation.

Wellmien Performance for Surgical Face Mask ASTM Level 3 Non Woven FDA510K:

Standard Class	Breathing Filtration Efficiency (BFE)	Breathing Resistance (mmH20/cm2)	Splash Resistance (mmHg)	Particulate Filtration Efficiency (PFE)
FDA 510K ASTM F 2100 Level 3	>99%	< 6,0	160	>99%

Shipping Port: Shanghai or Wuhan.

Packing Picture:

Remark: To better ensure the safety of your goods, professional, environmentally friendly, convenient and efficient packaging services will be provided.

FDA 510 K Requirements:

MEDICAL FACE MASK TESTS AND REQUIREMENTS U.S.A.: ASTM F2100-19 STANDARD SPECIFICATION FOR PERFORMANCE OF MATERIALS USED IN MEDICAL FACE MASKS
Test Item		ASTM F2100-19
		Level 1	Level 2	Level 3
Testing	BFE% ASTM F2101	≥95	≥98
	PFE% ASTM F2299	≥95	≥98
	Synthetic Blood ASTM F1862	Pass at 80mmHg	Pass at 120mmHg	Pass at 160mmHg
Physical Testing	Differential Pressure	<5.0 mmh2o="">	<6.0 mmh2o="">
Safety Testing	Flammablility 16 CFR Part 1610	Class 1 (≥ 3.5 seconds)
	Microbial Cleanliness ISO 11737-1	Not required
	Biocompatibility ISO 10993	510 K Guidance recommends testing to ISO 10993
Sampling ANSI/ASQC Z1.4 ISO 2859-1		1. AQL 4% for BFE,PFE, Delta P 2. 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤28 passing) 3. 14 masks for Flammability

[Scope of Application]:
Covers the mouth, nose, and jaw, providing a physical barrier against the direct penetration of pathogens, microorganisms, body fluids, and particles.

[Materials and Composition]:
The mask is made up of three key components:
Mask Body: It has three layers: an inner and outer layer of polypropylene (PP) non-woven fabric and a middle layer of PP melt-blown cloth.
Nose Clip: Galvanized iron wire coated with PE material.
Mask Band: Elastic spandex for a secure fit.

[Usage Instructions]:
Wearing the Mask:
Ensure the dark side faces outward and the light side touches your skin.
Position the nose clip over your nose and fully cover both the nose and mouth.
Loop the ear bands around both ears.
Use your fingertips to press the nose clip, starting from the center and working towards the edges, shaping it to the bridge of your nose.
Adjust the mask bands for optimal comfort.
Removing the Mask:
a) Avoid touching the front surface (contaminated area).
b) Remove the elastic bands from behind your ears.
c) Dispose of the mask by placing it in a clinical waste container.

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