Surgical face mask (F-Y3-A)

This product complies with the requirements of EU Regulation (EU) 2016/425 for Personal Protective Equipment and meets the requirements of European standard EN 149:2001+A1:2009. At the same time, it complies with the requirements of EU Regulation (EU) MDR 2017/745 on medical devices and meets the requirements of European Standard EN 14683-2019+AC:2019.

Intended use: This product is limited to surgical operations and other medical environment where infectious agents are transmitted from staff to patients. The barrier should also be effective in reducing oral and nostril discharge of infectious substances from asymptomatic carriers or clinically symptomatic patients and in protecting against solid and liquid aerosols in other environments.

User instructions：
The mask must be selected properly for intended application. An individual risk assessment must be evaluated. Check the respirator that is undamaged with no visible defects. Check the expiry date that has not been reached (see the packaging). Check the protection class that is appropriate for the product used and its concentration. Do not use the mask if a defect is present or the expiry date has been exceeded. Failure to follow all instructions and limitations could seriously reduce the effectiveness of this particle filtering half mask and could lead to illness, injury or death. A properly selected respirator is essential, before occupational use, the wearer must be trained by the employer in the correct use of the respirator in accordance with applicable safety and health standards.

Using method:
1. Hold the mask in hand with the nose clip up. Allow head harness to hang freely.
2. Position the mask under the chin covering mouth and nose.
3. Pull the head harness over the head and position behind head, adjust the length of head harness with adjustable buckle to feel as comfortable as possible.
4. Press soft nose clip to conform snugly around the nose.
5. To check fit, cup both hands over the mask and exhale vigorously. If air flows around nose, tighten the nose clip. If air leaks around the edge, reposition the head harness for better fit. Re-check the seal and repeat the procedure until the mask is sealed properly.

Performance: The product meets the requirements of EN 14683-2019+AC:2019 Type IIR. The main parameters of the product are listed in the following: •Bacterial filtration efficiency (BFE) ≥98% •Differential pressure 60＜Pa/cm2 •Splash resistance pressure ≥16.0 kPa •Microbial cleanliness, ≤ 30 cfu/g The product meets the requirements of EN149:2001+A1:2009 FFP2. The main parameters of the product are listed in the following: •Penetration rate ≤6%; •Expiratory resistance ≤3.0mbar; •Inhalation resistance ≤0.7mbar (30L/min); Inhalation resistance ≤2.4mbar (95L/min); •Leakage rate: TIL should be less than 11% based on the TIL of each action; TIL is less than 8% based on the overall TIL of people.

F-Y3-A is a surgical face mask and particle filtering half mask.

F-Y3-A has been testing according to EN 149:2001 +A1:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking

Test results

Package
Particle filtering half masks shall be offered for sale packaged in such a way that they are protected against mechanical damage and contamination before use. (Passed)

Material
Materials used shall be suitable to withstand handling and wear over the period for which the particle filtering half mask is designed to be used. (Passed)
Any material from the filter media released by the air flow through the filter shall not constitute a hazard or nuisance for the wearer. (Passed)

Practical performance
The particle filtering half mask shall undergo practical performance tests under realistic conditions. (Passed)

Finish of parts
Parts of the device likely to come into contact with the wearer shall have no sharp edges or burrs. (Passed)

Total inward leakage
For particle filtering half masks fitted in accordance with the manufacturer’s information, at least 46 out of the 50 individual exercise results (i.e. 10 subjects x 5 exercises) for total inward leakage shall be not greater than: 25% for FFP1, 11% for FFP2, 5% for FFP3

And, in addition, at least 8 out of the 10 individual wearer arithmetic means for the total inward leakage shall be not greater than 22% for FFP1, 8% for FFP2, 2% for FFP3 (Passed)

Compatibility with skin
Materials that may come into contact with the wearer’s skin shall not be known to be likely to cause irritation or any other adverse effect to health. (Passed)

Flammability
When tested, the particle filtering half mask shall not burn or not to continue to burn for more than 5 second after removal from the flame. (Passed)

Carbon dioxide content of the inhalation air
The carbon dioxide content of the inhalation air (dead space) shall not exceed an average of 1.0% (by volume). (Passed)

Head harness
The head harness shall be designed so that the particle filtering half mask can be donned and removed easily.
The head harness shall be adjustable or self-adjusting and shall be sufficiently robust to hold the particle filtering half mask firmly in position and be capable of maintaining total inward leakage requirements for the device. (Passed)