Disposable Surgical Mask  ( 510K)


Disposable Surgical Mask ( 510K)

Short Description:


3-layer breathable: 3 layers can better block small particles in the air and filter it to reduce stuffiness of wearing the mask.

Thoughtful design: The embedded nose clip can help fit the nose bridge and reduce fogging on glasses. Elastic ear loops: Highly elastic ear loops put little pressure on the ears and face, avoiding the discomfort associated with long-term use.

A MUST FOR PERSONAL AND HOME: Complete personal care kit for daily use, for home and office, school and outdoor, service workers and personal needs. The best gift for family and friends.

Product Detail

Product Tags

Medical Face Surgical Mask Disposable with Earloop Level1 510k Non Woven Blue Adult Class II ASTMF2100 Level 1

Product Name

ASTM F2100 Level 1 Face Mask


22g SPP+25g Melt-blown+18g SPP


CE, TGA, 510K, ISO13485


510K,ASTM F2100 Level 1 compliant with testing
for resistance to synthetic blood penetration

ASTM Level1/2/3

ASTM F2100



Product type

Head Tie Medical mask, EarLoop Medical Mask

ASTM F 2100 – Level 2 Barrier Protection


Testing Methodology

Acceptable Limits

Bacterial Filtration Efficiency (BFE)

ASTM F2101

BFE @ 3.0 µm large Bacteria ≥ 95%

Differential Pressure (∆P)


∆P < 4.0 mm of H2O/cm2

Particulate Filtration Efficiency (PFE)

ASTM F2299

PFE @ 0.1 µm large Latex particules ≥ 95%

Fluid Resistance

ASTM F1862

Resistant @ 80mmHg

Textile Flammability

16 CFR 1610

Class I flame spread




Sterile/NON Sterile



Carton Size


Production Capacity

3million/each day

USA Market

Yes, we have all Certificates and Testing Report for USA

market for ASTM F2100 Level1/2/3

EU Market

CE Certificates and Testing report, and Local Country

Language Package

Independent packaging

Yes, it can be 1pc/bag, 5pcs/bag, and 10pcs/bag

White List

China White List, Italy, Germany, Spain, Norway, Uk....

Government Supplier White List


Hospital, Laboratory, Home...

Single use

- This product is disposable. Do not use expired
- After the product is used, it shall be disposed according
to the applicable regulations.


Store away from harmful gases, light, in a ventilated and

dry place. Keep away from fire sources and

inflammable materials.

Features and usage method

This product is a medical device intended for medical

purposes which provides a physical barrier to resist liquid

penetration from
fluids and other potentially infectious materials.
1. Wash your hands with soap and water or an alcohol-based
hand rub.
2. Take out the face mask, put the side with nose clip of

mask upward and then put mask belt at both ends of ears.
3. Press the nose clip lightly to make it fit the nose beam,

then nose to the mandible to obtain the best protective effect.
5. Avoid touching the mask while using it; if you do, wash

your hands.
6. When the mask becomes damp, replace it with a new one.
7. Product usage not inten

Disposable Surgical Mask  ( 510K)
Disposable Surgical Mask  ( 510K)

  • Previous:
  • Next:

  • Write your message here and send it to us

    Product categories