[Product Name] Medical Surgical Mask

[Specification and model] Flat hanging ear 175mm × 95mm; Flat ear 175mm × 95mm

Folding ear 160mm × 105mm; Folding ear 160mm × 105mm

[Registrant/Enterprise Name] Jilin Fran Medical Technology Co., Ltd. [Domicile] Bingsan Road, Changde New District, Changchun, Jilin Province

[Production address] Bing30 Road, Changde New District, Changchun, Jilin Province [Production license number] Jishi Pharmaceutical Supervision Equipment Production License No. 20150048

[Contact Information] 0431-81851702

[Medical Device Registration Certificate No.] JiXZZ 20202140030 [Product Technical Requirements No.] JiXZZ 20202140030

The product mainly consists of a mask body, nose clip, and mask strap.

[Product Performance] 1. Specification and Size: It should meet the requirements of the design size, with an allowable deviation of 5mm.

2. Structure: After wearing the mask, it should be able to cover the wearer's nose, mouth, and jaw.

3. Appearance: The mask should have a clean and intact appearance, with no damage or stains on the surface.

4. Nose clip: The cover should be equipped with a nose clip, which is made of plastic material. The length of the nose clip should not be less than 8.0cm.

5. Mask strap: The mask strap should be easy to wear and remove. The breaking strength at the connection point between each mask strap and the mask body should not be less than 10N.

6. Synthetic blood penetration: After 2mL of synthetic blood is sprayed onto the outer side of the mask at a pressure of 16.0kPa (120mmHg), there should be no infiltration on the inner side of the mask.

7. Filtering efficiency

　　7.1 Bacterial filtration efficiency: The bacterial filtration efficiency of masks should not be less than 95%.

　　7.2 Particle filtration efficiency: The filtration efficiency of the mask for non oily particles should not be less than 30%.

8. Pressure difference: The pressure difference △ P between the two sides of the mask for gas exchange should not exceed 49Pa.

9. Flame retardant performance: The mask material should be made of non flammable materials; The mask shall not burn for more than 5 seconds after leaving the flame.

10. Sterility: The product should be sterile.

11. Residual amount of ethylene oxide: The residual amount of ethylene oxide should not exceed 10 μ G/g.

[Scope of Application] For clinical medical personnel to wear during invasive procedures, covering the user's mouth, nose, and jaw, providing a physical barrier to prevent direct passage of pathogenic microorganisms, bodily fluids, particulate matter, etc.

[Contraindications] None.

[Precautions, Warnings, and Indicative Notes]

1. Before use, first check the validity period of the product, if it exceeds the validity period