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1. Mask Description
|
Item |
Description |
|
Product Name |
Cornmi Disposable Medical Mask/Mask, Surgical (ASTM LEVEL 3) |
|
Certificate |
FDA |
|
Material |
1) Breathable Material: The face mask is made of high-quality non-woven Breathable fabric with a stronger filtering effect and is more safe, soft, skin-friendly, and easy to use; 2) Made of Meltblown Non-Woven Fabric: 2+1(Filter Layer = Meltblown 25g BFE99) Ply Super Filter Pollen Dust and Bacteria; |
Level 3 Earloop Medical Procedure Mask features slip-on convenience, provides fluid resistance and => 95% Bacterial Filtration Efficiency (BFE).
Specification & Certification:
- ASTM Minimal Standard: High Barrier
- High fluid resistance: 160mmHg (Type IIR)
- PFE: > 99%
- BFE: > 99% (Type IIR)
- Breathability - Delta P: < 5.0 H2O/cm² (Type IIR)
- Flame Spread: Class I
- Certification: CE, FDA, ISO13485, EN14683
- Fluid resistant outer layer: ASTM F2100
- Fluid resistant inner layer: NELSON
- Non Sterile
ASTM performance metrics and levels
| Test |
ASTM Level 1 |
ASTM Level 2 |
ASTM Level 3 |
|
Fluid Resistance |
80 mmHg |
120 mmHg |
160 mmHg |
| Filtration – BFE |
> 95% |
> 98% |
> 98% |
| Filtration - PFE |
> 95% @ 0.1 µg |
> 98% @ 0.1 µg |
> 98% @ 0.1 µg |
| Delta P - Breathability |
< 4.0 mm H2O/cm3 |
< 5.0 mm H2O/cm3 |
< 5.0 mm H2O/cm3 |
|
Flame Spread |
Class 1 | Class 1 |
Class 1 |
A procedural mask is designed for use when performing patient procedures or when a patient is in isolation to protect the patient from contaminants. Procedure masks protect both the patient and health-care provider from transferring respiratory secretions, bodily fluids, or other potentially infectious material. Procedure masks have ear loops rather than ties.
How to view our FDA Certification
1) You can find our Registration on “U.S. Food and Drug Administration”:
Website：https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Step1: Enter “Shenzhen tonghua” as below and press “Search”.
Step2: After Search，you will find below.
Step3: For Establishment Info.Please press “SHENZHEN TONGHUA WEIYE TECHNOLOGY CO. LTD”
Step4: For Mask Info.Please press “CORNMI Disposable Medical Mask CM2001; CORNMI Disposable Medical Mask CM2007; CORNMI Disposable Medical Mask CM2009；CORNMI N95 Face Mask CM2003; shunmei N95 face mask PFM-001”
Test Report
Warnings
This device is not designed, sold, or intended for use except as indicated. This mask is not a respirator.
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