Disposable Latex-Free Non-Sterile Surgical Face Mask 3-Ply Medical Protective Mask for Healthcare Use

• Customization: Available
• Type: Face Mask/Apron/Gloves
• Material: Non-Woven Fabric, Nonwoven Fabric
• Model NO.: WELLMIEN-FM0045
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: Five Years
• Group: Adult or Children
• Logo Printing: With Logo Printing
• Composition: Fiberglass Free and Latex Free
• Color: Blue, Green, White, Pink
• Size: 17.5*9.5cm;14.5*9.5cm
• Classify: Disposable Latex Free Nonsterile Surgical Face Mas
• Application: Hospital, Clinic, House, Food Processing Place
• Transport Package: 50PCS/Box, 40boxes/CTN, 50PCS/Bag, 40bags/CTN
• Specification: CE/ISO13485
• Trademark: WELLMIEN or OEM
• Origin: Jiangsu, China(Mainland)
• HS Code: 6307900090
• Production Capacity: 10, 000, 000 PCS / Month

Product Description

HOT PRODUCT

Disposable Latex-Free Non-Sterile Surgical Face Mask 3-Ply Medical Protective Mask for Healthcare Use

Product Description

Attribute	Details
Material	3-layer nonwoven fabric (Spunbond + Melt-blown + Spunbond)
Style	Earloop or Tie-on
BFE (Filtration)	≥ 98% (Bacterial Filtration Efficiency)
Color	Blue / White / Green / Customized
Size	17.5 x 9.5 cm
Sterility	Non-sterile
Latex-Free	Yes
Application	Medical clinics, hospitals, patient protection
Certifications	CE, ISO13485, EN14683 Type I/II/IIR
Packaging	50 pcs/box, 2000 pcs/carton or as required

Key Features

• Latex-Free Design
  Safe for users with latex allergies-ideal for universal hospital use.

• Triple-Layer Protection
  Filters out airborne particles and bacteria effectively with melt-blown inner layer.

• Comfortable and Breathable
  Soft nonwoven inner layer for skin comfort during extended wear.

• Flexible Fit
  Nose bar adjustment and elastic earloops or secure tie-on options.

• Medical-Grade Material
  Produced in ISO-certified facilities for consistent quality assurance.

Detailed Photos

Product Benefits

• Reduces risk of cross-contamination

• Easy to wear and remove

• Suitable for non-sterile environments like general checkups or outpatient clinics

• Cost-effective protection for staff and patients

• Custom packaging and logo options available

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

<5.0 mmh2o=""><6.0.<><5.0 mmh2o=""><6.0 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.

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