Surgical/Hospital/Medical/Protective/Safety/Nonwoven Face Mask with ISO Certificate
Wuhan Xinhengyue Industrial&Trade Co., Ltd. / 2022-06-23
- 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
=== Base Info ===
- 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
=== Description ===
Basic Info.
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 certaincircumstances to protect the wearer against splashes of potentially contaminated liquids and viable particles, also worn bypatients 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, afterETO sterilization, the product is non-toxic, non-bacterial and pyrogen-free. 1.2 Accessories and ComponentsNo. | 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-8.7cm1.3.1.3: Strength The belt separated with face shield should more than 10N: 15N1.3.1.4: Other Dates: According to EN 149 and EN14683Test 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/g1.4 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 case4 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 facebetter.5. Check air impermeability: Hands cover the mask to exhale without moving, adjust the metal nose clip if feel air leakingfrom nose clip; Or adjust belts if feel air leaking from flanks.