En14683 Type Iir Disposable 3-Ply Surgical Face Mask with Splash Resistance

• Customization: Available
• Type: Face Mask/Apron/Gloves
• Material: Non-Woven Fabric, Nonwoven Fabric
• Model NO.: WELLMIEN-FM0055
• 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

EN14683 Type IIR Disposable 3-Ply Surgical Face Mask with Splash Resistance

Product Description

Our Disposable Non-Woven EN14683 Type IIR Surgical Mask is designed for professional medical and healthcare environments requiring high filtration efficiency and fluid resistance.

Manufactured with a 3-layer non-woven structure, this medical face mask provides effective bacterial filtration while maintaining breathability for extended wear.
The Type IIR standard offers additional splash resistance, making it suitable for hospitals, clinics, dental practices, and medical procedures with exposure risk.

Soft ear loops and an adjustable nose clip ensure a secure and comfortable fit.
As a professional B2B trading company, we support stable bulk supply, OEM customisation, and export-compliant production.

Attribute	Details
Product Name	Disposable Non-Woven EN14683 Type IIR Surgical Mask
Material	Nonwoven Fabric + Meltblown Filter
Structure	3-Ply with Earloop / Tie-on
BFE (Bacterial Filtration Efficiency)	≥ 98% (Type IIR)
Splash Resistance	≥ 16.0 kPa (Type IIR)
Color	Blue / Green / White / Black / Customized
Size	17.5 × 9.5 cm (Adult) / Customized
Packaging	50 pcs/box, 2000 pcs/carton or as required
Feature	Hypoallergenic, Breathable, High Filtration, Splash Resistant
Usage	Medical, Surgical, Public Protection
Certification	CE / EN14683 / ISO13485 / FDA (on request)
Shelf Life	2-3 years

Our Disposable Non-Woven EN14683 Type IIR Surgical Mask offers premium protection and comfort for medical professionals and public health applications. Manufactured from high-quality nonwoven fabric with a melt-blown filter layer, this 3-ply mask meets EN14683 Type IIR standards with BFE ≥98% and excellent splash resistance.

The hypoallergenic and latex-free earloops ensure a secure, comfortable fit even for extended wear. Adjustable nose clips improve sealing to reduce fogging and leakage. Individually packed or bulk supply available for hospitals, clinics, laboratories, and distributors worldwide.

Why Choose Our Type IIR Surgical Mask:

• Certified Protection: Meets EN14683 Type IIR standard with splash resistance.

• 3-Ply High Filtration: Outer hydrophobic layer + melt-blown filter + soft inner layer.

• Comfortable Fit: Hypoallergenic, latex-free earloops and adjustable nose bridge.

• Breathable Design: Ensures easy breathing while maintaining protection.

• Bulk Supply & OEM Service: Customized packaging and branding available.

Applications:
Hospitals, clinics, dental offices, laboratories, emergency services, and public health protection.

Detailed Photos

 

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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