Surgical/Hospital/Medical/Protective/Safety/Nonwoven Face Mask with ISO Certificate

• Type: Face Mask/Apron/Gloves
• Color: Blue or White for Otpion
• Delviery Time: 7 Days
• Material: Non-woven Fabric
• Certification: ISO13485
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult
• Logo Printing: OEM
• Transport Package: Carton
• Specification: 420*280*180cm
• Trademark: customized
• Origin: China
• HS Code: 6307900000
• Production Capacity: 20, 000, 000

Product Description

Medical Face Mask
 

 
1. General description of products and accessories
1.1 Device Description
The Medical Face Mask for single use is intended to protect the patient from infective agents and, additionally, in certain
circumstances to protect the wearer against splashes of potentially contaminated liquids and viable particles, also worn by
patients and other persons to reduce the risk of spread of infections in epidemic or pandemic situations 
The Medical Face Mask for single use is assembled by belt , face shield and nose bridge. 
All materials includes non-woven fabric, melt blown and Metal, used in this product can meet medical requirement, after
ETO sterilization, the product is non-toxic, non-bacterial and pyrogen-free. 

1.2 Accessories and Components

No.	Name	Material
1.	Belt	Polypropylene fiber
2.	3 layer face shield	non-woven fabric + melt blown
3.	nose bridge	PP + Iron

1.3 The main technique parameter of product
1.3.1 Physics requirement
1.3.1.1 Appreance
The surface should be smooth, freedom from unwanted foreign matter, dirty.
1.3.1.2 Instruction and Size: 
The belt should be 22cm-23cm and the nose bridge should be 8.3cm-8.7cm
1.3.1.3: Strength 
The belt separated with face shield should more than 10N: 15N
1.3.1.4: Other Dates:  According to EN 149 and EN14683

Test Item	Bacterial  Filtration Efficiency (BFE)	Partical  Filtration Efficiency (PFE)	Differential Pressure ( Pa/cm2)	Splash  Resistance Pressure (Kpa)	Microbial Cleanliness
Result	98%-99.5%	97%-99%	40-42	20	15

1.3.2     Chemical requirement
1.3.2.1   EO residual
Each infusion set EO residual is less than 10ug/g: 2 ug/g
1.4     Biology requirement
Product sterility, pyrogen, and the bio-compatibility requirements comply with the ISO10993.
2  Function & Caution
Please pay attention to following instructions when you use it, as a disposable medical instrument:
*  Don't use if package is open or damaged;
*  For single use only discard after use;
*  Use it within the valid date;
*  Use it immediately when individual package opened.
 
3 Packaging
The Medical Mask is supplied sterile in Paper-plastic bag package, inner box and corrugated shipping case. 
30pcs to box and 600 pcs to case

4 Sterilization
Sterilized by shanghai kindly itself with ETO
 
5.0 Instruction for use
1. Facing the side of mask without nose clip and place the metal nose clip upward.

2. Hold the mask on face against your chin with one hand, pull the nether belt over your head below the ears.
3. Pull the upper belt over your head above the ears.
4. Place fingers on the metal nose clip, press and move fingers tip along the nose bridge to ensure the mask fitting face
better.
5. Check air impermeability: Hands cover the mask to exhale without moving, adjust the metal nose clip if feel air leaking
from nose clip; Or adjust belts if feel air leaking from flanks.