[product name] chitosan dressing

[specification and model] model: non self adhesive type (type I), self-adhesive type (type II), specification: length (5-200) cm × width (5-200) cm

[name of registrant] Henan Jianqi medical device Co., Ltd

[address] dingluan Industrial Zone, Changyuan County, Henan Province

[Tel.] 0373-8690789

[after sales service unit] Henan Jianqi medical equipment sales Co., Ltd

[name of manufacturer] Henan Jianqi Medical Equipment Co., Ltd

[address] dingluan Industrial Zone, Changyuan County, Henan Province

[production address] dingluan Industrial Zone, Changyuan County, Henan Province

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20182140487

[structure composition] non self adhesive chitosan dressing is made of chitosan nonwovens.

Self adhesive chitosan dressing is composed of chitosan nonwovens, medical pressure-sensitive adhesive tape and release paper.

[product performance]

1. The four sides of chitosan dressing should be neat without burr, and the surface should be clean and flat without damage and stain, and the edges of each component should be cut neatly;

2. The specification of chitosan nonwovens should not be less than 30g / m2.

3. The antibacterial rate of chitosan nonwovens to Escherichia coli, Staphylococcus aureus and Candida albicans should be more than 26% (insoluble).

4. The pH value of chitosan nonwovens test solution should be between 6.0 and 7.5. 5. The chitosan content of chitosan nonwovens is more than 80%;

6. The content of heavy metal in chitosan is less than 10 μ g / g;

7. Chitosan nonwovens should have good liquid absorption, and the liquid absorption of chitosan dressing should not be less than 0.1g/10cm2;

8. The size of release paper on chitosan dressing should not be less than 30g / m2.

9. The adhesion of adhesive tape shall not exceed 2.5 mm when it is pasted on stainless steel plate.

10. The peel strength of pressure-sensitive adhesive tape for chitosan dressing should be no less than 1.0N per 1cm width.

11. The air permeability of adhesive tape shall be no less than 500g / m2 every 24h.

12. The water resistance of the adhesive tape does not appear the water seepage phenomenon of the breathable adhesive tape.

13. Chitosan dressing should be sterile;

14. After sterilization with ethylene oxide, the residual amount of ethylene oxide should not be more than 10 μ g / g.

[scope of application] it is suitable for the nursing of traumatic wound, surgical incision and infectious wound.

[contraindications] it is forbidden for those allergic to chitosan nonwovens or its components (i.e. shrimp, crab shell, etc.).

[precautions]

1. This product belongs to disposable goods, the package is damaged, it is strictly prohibited to use, and it will be destroyed after use.

2. The production batch number and expiration date are shown in the seal of the package, and the sterilization date is shown in the outer packing box.

3. This product is sterilized by ethylene oxide and has a sterility validity of two years.

4. The patient with allergic constitution should be used with caution. When the wound is seriously infected, it should be used under the guidance of a doctor.

[usage]

1. According to the needs, select the corresponding specifications and models, cover the wound surface, and gently press;

2. For large area wounds, multiple products can be used for docking and covering completely.

[storage method]

1. This product should be loaded and transported in the covered carriage and cabin, and kept clean. It should not be under heavy pressure, direct sunlight and rain and snow.

2. Handle with care to avoid violent collision;

3. The product should be stored away from the fire source, the relative humidity is not more than 80%, no corrosive gas and well ventilated and clean environment.