Disposable 3-Ply Surgical Non-Woven Medical Respirator Mask with High Bacterial Filtration

• Customization: Available
• Standard: EN14683-2019
• Filter Rating: Normal
• Model NO.: WELLMIEN-FM0010
• Available Times: Disposable
• Type: Medical Surgical Mask
• Layers: 3 Ply
• Style: Earloop
• Shape: Flat
• Sterilization: Sterilization
• Age Group: Adult
• Color: White/Blue/Green/Yellow etc.
• Size: Adult: 17.5*9.5cm / Child: 14.5*9.5cm
• Layer: 3ply
• Nose Clip: Single Nose Wire/Double Nose Wire/Plastic Nose Cli
• Certificate: Ce, ISO 13485, FDA 510(K)
• Sterile: Nonsterile
• Material: Non-woven Fabric
• Certification: CE, FDA, ISO13485
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Logo Printing: With Logo Printing
• Group: Adult & Child
• Transport Package: 50PCS/Box, 40boxs/CTN
• Specification: Adult: 17.5*9.5cm; Child: 14.5*9.5CM
• Trademark: WELLMIEN OR OEM
• Origin: Jingsu, China(Mainland)
• HS Code: 63079000
• Production Capacity: 9000000PCS/Month

Product Description

HOT PRODUCT

Disposable 3-Ply Surgical Non-Woven Medical Respirator Mask with High Bacterial Filtration

Product Description

Attribute	Details
Material	Non-woven PP (outer + inner) + Melt-blown filter layer
Layer Composition	3 layers: Outer hydrophobic layer, middle melt-blown filter, inner soft layer
Bacterial Filtration Efficiency (BFE)	≥98% (Type II / Type IIR compliant)
Particulate Filtration Efficiency (PFE)	≥95%
Fluid Resistance	Optional Type IIR: 120 mmHg fluid resistance
Size	17.5 x 9.5 cm (adult size); custom sizes available
Nose Clip	Adjustable metal nose bridge for a secure fit
Earloop Type	Elastic, latex-free, soft and stretchable
Color Options	Blue, white, green, black, pink, custom colors available
Packaging	50pcs/box, 2000pcs/ctn; custom packaging available
Sterilization	Non-sterile (sterile version available upon request)
Certifications	CE, ISO 13485, EN14683 Type I / II / IIR, FDA (optional)
Usage	Single-use only

Key Features

• Certified 3-Layer Protection
  Effective filtration of airborne particles, droplets, bacteria, and dust.

• Comfortable for Extended Wear
  Soft inner layer and elastic earloops reduce ear pressure and skin irritation.

• Adjustable Nose Clip
  Ensures better sealing, helps prevent fogging for eyeglass wearers.

• Medical-Grade Quality
  Suitable for hospital, surgical, dental, and clinical use-complies with EN14683.

• Ready for Bulk Supply
  Packaged for clinics, hospitals, schools, businesses, and institutions.

Packaging & Shipping

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
Barrier 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

[Raw Materials, Structure and Composition of the Product]:
The product consists of a mask body, a nose clip, and a mask band. The mask body is divided into three layers: inner and outer layers are polypropylene (PP) non-woven cloth, and the middle layer is polypropylene (PP) melt-sprayed cloth. The nose clip is made of galvanized iron wire with PE material. The masked band is spandex.

[Product Contraindications]: None.

[Usage]:
How to wear the mask:

1. The dark side of the mask should be worn on the outside, while the light side should be close to the mouth. The nose clip should be put on the nose, and the mask should cover the nose and mouth. Two elastic ear-loops hang on each ear.
2. Put the fingertips on the nose clip, start from the middle, press onward with the fingers and gradually move to both sides, and shape the nose clip according to the shape of the bridge of the nose;
3. Adjust the mask belt appropriately according to personal comfort.

How to remove mask:
a)Do not touch the front of the mask (contaminated surface).
b)Remove elastic bands from both ears.
c)The elastic band used to hold the mask only is thrown into the clinical waste container.

Detailed Photos

Specification:

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

2. Glass fiber-free and latex-free.

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

<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
Barrier 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

<5.0 mmh2o=""><6.0 mmh2o=""><5.0 mmh2o=""><6.0 mmh2o="">[Scope of Application]: It covers the user's mouth, nose, and jaw to provide a physical barrier against the direct penetration of pathogens, microorganisms, body fluids, particles, etc.

[Raw Materials, Structure and Composition of the Product]:
The product consists of a mask body, a nose clip, and a mask band. The mask body is divided into three layers: inner and outer layers are polypropylene (PP) non-woven cloth, and the middle layer is polypropylene (PP) melt-sprayed cloth. The nose clip is made of galvanized iron wire with PE material. The masked band is spandex.

[Product Contraindications]: None.

[Usage]:
How to wear the mask:

1. The dark side of the mask should be worn on the outside, while the light side should be close to the mouth. The nose clip should be put on the nose, and the mask should cover the nose and mouth. Two elastic ear-loops hang on each ear.
2. Put the fingertips on the nose clip, start from the middle, press onward with the fingers and gradually move to both sides, and shape the nose clip according to the shape of the bridge of the nose;
3. Adjust the mask belt appropriately according to personal comfort.

How to remove mask:
a)Do not touch the front of the mask (contaminated surface).
b)Remove elastic bands from both ears.
c)The elastic band used to hold the mask only is thrown into the clinical waste container.

OUR TOP 10 SALES PRODUCT

OUR OTHER PRODUCT