Sinsoon Medical Surgical Mask (50-piece)

Medical Surgical Mask (50-piece; Polypropylene)

Coronavirus (Covid-19) Flat Ear-loop Face Mask

Disposable Medical Surgical Mask Instruction

[Product Name] Surgical Mask

[Model and Specification] Ear-loop Face Mask 175mm*95mm (non-sterile), Ear-loop Face Mask 145mm*90mm (non-sterile), Ear-loop Face Mask 125mm*80mm (non-sterile)

[Production License No.] 鄂食药监械生产许20200946号

[Product Technical Requirements No.] 鄂械注准20202143035

[Medical Device Registration Certificate No.] 鄂械注准20202143035

[Components]

This product is composed of a mask body, a nose clip, and mask belts. The mask body has three layers: the inner and outer layers are made of polypropylene non-woven fabric, and the middle filter layer is made of polypropylene melt-blown fabric. The nose clip is a thin galvanized iron wire wrapped in the mask body. The mask belts are made of elastic spandex and inelastic polyester. Each mask is packed separately in the package.

[Product Performance]

·       The appearance of the mask shall be clean and in good shape, and the surface shall not be damaged or stained.

·       After wearing the mask, it should be able to cover the nose, the mouth, and the jaw of the wearer. It must fit the design size and the tolerance should be within 5%.

·       The mask should be equipped with a nose clip, which is made of plastic material. The length of the nose clip should not be less than 8.0 cm.

·       The mask belt should be easy to wear and take out. The breaking strength at the connection point between each mask belt and the mask body shall not be less than 10N.

·       After 2ml synthetic blood was sprayed to the outer side of the mask at a pressure of 16.0kpa (120mmHg), there should be no penetration to the inner side of the mask.

·       The bacterial filtration efficiency of the mask should not be less than 95%;

·       The filtration efficiency of the mask for non-oily particles should not be less than 30%.

·       Pressure difference of the gas exchange between two sides of the mask should not be greater than 49 Pa.

·       The mask material should be non-flammable; the combustion time of the mask after leaving the flame is no more than 5 s.

·       No Coliform, Pseudomonas aeruginosa, Staphylococcus aureus, Hemolytic streptococcus, and Fungi should be detected in the mask, and the total bacterial colony count is less than or equal to 100 CFU/g.

[Applications]

It is used for covering the mouth, the nose, and the jaw of medical staff in the operating room to prevent the spread of dander and respiratory tract microorganisms to the surgical wound, and prevent the body fluid of patients from spreading to medical staff, so it plays the role of two-way biological protection (the product needs to be sterilized before entering the operating room).

[Contraindications] Use with caution if you are allergic to thin nonwovens.

[Directions]

1. Take out the medical surgical mask.

2. Wear the colored side outward.

3. Press the nose clip tightly on the nose to fit the nose and prevent air leakage.

4. Pull the lower end of the mask to the lower jaw.

[Cautions]

1. Before using the mask, check whether the mask package is in good condition.

2. After unpacking, it should be used as soon as possible.

3. After wearing the mask, avoid touching the inner side of the mask.

4. The mask should be discarded beyond the expiration date or if the production date and the batch number are ambiguous.

5. If the package is cracked or damaged, do not use it.

6. Before entering the operating room, the product needs to be sterilized, and ethylene oxide sterilization is recommended.

7. This product is a disposable product, do not reuse it.

8. The mask can only be used by medical personnel or related personnel, and cannot be used as a protective mask.

9. After use, the product should be folded and discarded in the medical garbage can.

[Storage Method] The packed medical masks should be stored in a cool, well-ventilated, and clean warehouse with a relative humidity of less than 80%.

[Production Batch Number] See packaging

[Production Date] See packaging

[Validity Period] Two years

[Registrant/manufacturer/after-sales service unit] Wuhan Reshinean Technology Co., Ltd.

[Registrant Address] No.16-2, Shangkong Huading Industrial Park, Chuangye Avenue, Gedian Development Zone, Ezhou City, Hubei Province, China

[Production Address] Building 30, Donghu High-tech Smart City, Gedian Development Zone, Ezhou City, Hubei Province, China

[Preparation Date of Instruction] April 10, 2021