[product name] disposable operating clothes

[specification and model] type I and type II

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

[residence] dingluan Industrial Zone, Changyuan County

[Tel.] 0373-8690789

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

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

[residence] dingluan Industrial Zone, Changyuan County

[production address] dingluan Industrial Zone, Changyuan County

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20172640086

[technical requirements No.] yxzz 20172640086

[structure and composition] the surgical dress is composed of the front, back, sleeve and lace.

Disposable operating suit.jpg

[product performance] 1. The operating clothes shall be free from mildew, damage, stain and impurities; the stitched surgical clothes shall be uniform, straight, without creases, needle skipping, stitching and leakage; the hot pressed surgical clothes shall be hot pressed evenly, straight, without wrinkle or leakage.

2. The gram weight of nonwovens used in surgical clothes should not be less than 20g / m2; the longitudinal breaking strength of nonwovens should be greater than or equal to 13N, and the transverse breaking strength should be greater than or equal to 8N. 3. The distance between stitches shall not be less than 24 stitches per 10 cm. 4. If there is chest film on the chest of operating clothes, but the size of nonwovens, coated nonwovens or plastic films should not be less than 40cm × 60cm; the nonwovens should not be less than 20g / m2; the longitudinal breaking strength of nonwovens should be greater than or equal to 13N, The transverse breaking strength should be greater than or equal to 8N; the coated nonwovens should not be less than 35g / m2; the film should be flat, without bubbles and separation; the plastic film should not be damaged, the thickness of plastic film should not be less than 0.01mm; there should be no damage, the thickness of plastic film should not be less than 0.01mm. 5. The non-woven fabric used for surgical sleeve should not be less than 35g / m2, the film should be flat, without bubbles and separation; the plastic film and plastic film should not be damaged, and the thickness of plastic film should not be less than 0.01mm (if any). 6. The sewing or hot pressing part shall be firm, and the firmness shall not be less than 10N; the breaking strength of the joint between each tie and the operating clothes shall not be less than 10N. 7. The performance of operating clothes should meet the requirements of Table 2. 8. When the suture fluorescent substance is tested according to test a in Appendix D of YY 0594-2006 standard, the suture shall not show strong blue fluorescence; the total amount of soluble matter in water shall not exceed 0.50%. 9. The operating clothes should be sterile. 10. After sterilization with ethylene oxide, the residual amount of ethylene oxide should not exceed 10ug / g.

[scope of application] it can be worn by the operating personnel to reduce the spread of infection source to the operation wound of patients to prevent postoperative wound infection; it can also reduce the risk of infection source carried in blood or body fluid to the operator.

[contraindications] no contraindications.

[precautions] 1. This product is disposable and its package is damaged. It is forbidden to use it and destroy it after use.

2. See the seal or label of the package for the batch number and the outer packing box for the sterilization date.

3. The product was sterilized by ethylene oxide.

[usage] 1. Select the applicable specification and model, and open the package after confirming that the outer package is in good condition.

2. After gently unfolding the operating clothes, extend both arms into the sleeves, and tie the clothes and tie, and tie the waist tightly.

3. After the end of use, the product should be treated as medical waste to avoid pollution.

[storage method] 1. The product should be loaded and transported in covered carriage and cabin, and kept clean. It should not be under heavy pressure, direct sunlight, rain or 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.