Factory making Hospital Household Equipment - Disposable Surgical Mask ( 510K) – Jinlian

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

Material

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

Certificates

CE, TGA, 510K, ISO13485

Standard

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

ASTM Level1/2/3

ASTM F2100

Size

17.5×9.5cm

Product type

Head Tie Medical mask, EarLoop Medical Mask

ASTM F 2100 – Level 2 Barrier Protection

Characteristic

Testing Methodology

Acceptable Limits

Bacterial Filtration Efficiency (BFE)

ASTM F2101

BFE @ 3.0 µm large Bacteria ≥ 95%

Differential Pressure (∆P)

MIL-M-36954C

∆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

Color

Blue/Black/White

Sterile

Sterile/NON Sterile

Package

50pcs/box;2000pcs/ctn

Carton Size

54x49x39cm

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

Applications

Hospital, Laboratory, Home…

Single use

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

Storage

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.
FEATURES AND USAGE METHOD
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