Disposable Nonwoven FDA 510K ASTM Level 3 Surgical Face Mask

• Customization: Available
• Standard: ASTMF2100
• Filter Rating: Bfe99%
• Model NO.: WELLMIEN-FM0015
• Available Times: Disposable
• Type: Surgical Supplies Materials
• Layers: 3 Ply
• Style: Earloop
• Shape: Flat
• Sterilization: Non Sterilization
• Age Group: Adult
• Color: White, Green, Blue ..
• Size: 17.5*9.5cm
• Function: Protection for Operation
• Classify: Bfe 99% 3ply Ear-Loop Pleated Surgical Face Mask
• Application: Hospital, Medical, Dental, Daily Use
• Material: Non-woven Fabric
• Certification: CE, FDA, ISO13485
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Group: Adult
• Logo Printing: With Logo Printing
• Quality Guarantee Period: Five Years
• Transport Package: 50PCS/Box, 40boxes
• Specification: CE, ISO13485
• Trademark: WELLMIEN OR OEM
• Origin: Jiangsu
• HS Code: 6307900090
• Production Capacity: 6, 000, 000 Pieces / Month

Product Description

Disposable Nonwoven Surgical Face Mask - ASTM Level 3, FDA 510(k) Certified, 3-Ply Medical Mask for Hospital Use

Product Description

Parameters

Attribute	Details
Product Name	Disposable ASTM Level 3 Surgical Face Mask
Material	Nonwoven Polypropylene (3-layer structure)
Layers	3-Ply: Outer hydrophobic layer + Melt-blown filter + Inner soft layer
BFE / PFE Efficiency	≥ 98% (Bacterial & Particle Filtration Efficiency)
Fluid Resistance	ASTM F1862: 160 mmHg
Flammability	Class 1 (Normal Flammability)
Breathability	Delta P < 5.0 mm HO/cm² (comfortable for extended wear)
Color Options	Blue, Green, White, Pink (custom colors available)
Size	17.5 x 9.5 cm (Adult)
Earloop	Elastic earloops, latex-free
Nose Clip	Adjustable aluminum strip for secure fit
Sterility	Non-sterile (sterile version available on request)
Certifications	FDA 510(k), ASTM F2100 Level 3, CE, ISO13485
Packaging	50 pcs/box, 2000 pcs/carton (custom packaging available)
Usage	Single-use, Disposable

  
Features

• ASTM Level 3 Protection:
  Offers the highest level of fluid resistance and filtration for surgical environments and high-risk procedures.

• FDA 510(k) Cleared:
  Approved for use in hospitals, clinics, and surgical settings in accordance with US regulatory standards.

• Triple-Layer Design:
  Combines comfort and maximum protection with high-efficiency melt-blown filter in the middle.

• Comfortable Fit:
  Soft inner layer, elastic ear loops, and adjustable nose clip ensure secure and comfortable all-day wear.

• High Breathability:
  Designed to maintain airflow while offering advanced particulate and fluid protection.

• Latex-Free & Hypoallergenic:
  Safe for users with sensitive skin or allergies.

Detailed Photos

 

Product Feature

[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.
 

Packaging & Shipping

Packing:

Normal Packing	QTY (pc)	Carton Size (cm)	N.G (kg/ctn)	W.G (kg/ctn)	Production 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.

Shipping Port: Shanghai or Wuhan.
Packing Picture:

One-stop shopping

If you like, you can choose other styles of masks:

Supporting protective equipment (simple protective bag)