FDA EUA Instruction: KN95

FDA EUA Instruction: KN95 

User Instructions

Models:  Flat Fold

Warnings and Limitations

Failure to follow all instructions and limitations on the use of these respirators and/or failure to wear these respirators during all times of exposure can reduce effectiveness and may result in sickness or death. For additional information please contact us at www.yadugroup.com or call +86-0373-8883000 (China) or +1-608-217-9358 (US FDA Agent)

Intended Use

The device is used as non-powered air-purifying medical protective face mask which can filter solid and airborne particles and block droplets, blood, body fluids, secretions, etc. under medical or non-medical settings.

Use Instructions

1. These respirators meet the requirements of GB 19083-2010, filtering facepiece respirators for use against particles. They should be used to protect the wearer from solid and airborne particles, and block droplets, blood, body fluids, secretions, etc.

2. Proper selection, training, use and appropriate maintenance are essential in order for the respirator to help protect the wearer from certain airborne contaminants. Failure to follow all instructions on the use of these respiratory protection and/or failure to properly wear the complete respirator during all periods of exposure may adversely affect the wearer’s health, lead to severe or life threatening illness or permanent disability.

3. Always check that the respirator is within the stated period of validity (use by date).

4. Before use, the wearer must be trained in use of the complete respirator in accordance with Health and Safety standards/guidance.

5. These respirators do not contain components made from natural rubber latex.

6. These respirators do not protect against gases/vapors.

7. Not to be used on children.

8. Do not use in atmospheres containing less than 18% oxygen.

9. Do not use for respiratory protection against atmospheric contaminants/concentrations which are unknown or immediately dangerous to life and health (IDLH).

10. Do not use with beards or other facial hair. They may inhibit contact between the face and the respirator thus preventing a good seal.

11. Leave the contaminated area immediately if:
a) Breathing becomes difficult.
b) Dizziness or other distress occurs.

12. Always be sure you are using the complete respirator.

13. The respirator is suitable for medical and non-medical application.

14. The respirator is worn during all periods of exposure.

15. Replace respirator when necessary.

16. Discard and replace the respirator if it becomes damaged, breathing resistance becomes excessive or at the end of the shift.

Fit Check

1. Wash your hands before wearing the mask and avoid any touch to your face during wearing.

2. Keep the mask flat and the inner surface to the upside after taking off, and fold it slightly and keep in the shade when necessary to avoid the breaking the nose clip.

3. Do not use when you have dyspnea or in sleep.

4. Not recommend to the children.

5. Do not use when the oxygen density <18%

6. Do not wash or flush

7. Please follow the guidance above to protect from infection

Fitting Instructions

8. Keep your hand dry and unfold the mask.

9. Keep the inner side to your face and the nose clip along to the upside.

10. Hang on to your face with the earloops and adjust the both loops even, then press the nose clip.

11. Adjust the facemask to the most fit of your face in each side. 

Cleaning Instructions

1. Do not alter, modify, clean or repair this respirator.

2. Dispose in accordance with local regulations.

Storage and Transportation

3. Store in accordance with manufacturer’s instructions.

4. Storage temperature should be between -20°C and +38 °C.

5. Storage humidity should be less than 80%.

6. When storing or transporting this respirator use original packaging provided.

7. Do not store in direct sunlight.

Classification

KN: Suitable for non-oily particles;

KN90: Filtration efficiency is ≥90%;

KN95: Filtration efficiency is ≥95%;

KN100: Filtration efficiency is ≥99.97%.