[product name] disposable package

[specification and model] type I (spontaneous delivery) type II (cesarean section type)

[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 20172640088

[technical requirements No.] yxzz 20172640088

[structure and composition] type I (spontaneous delivery type) and type II (cesarean section type) are composed of basic configuration and optional configuration. Type I (natural birth type) basic configuration: disposable medical pad, disposable treatment towel, trouser leg; type II (caesarean section type) basic configuration: disposable medical pad, disposable hole towel, disposable treatment towel, trouser leg. Selection and configuration: disposable medical rubber inspection gloves, disposable mask, disposable hat, disposable operating clothes, medical absorbent gauze block, umbilical cord protection, umbilical cord clip, umbilical cap, umbilical cord cord, medical cotton swab, medical cotton ball, disposable medical wrapping cloth, medical suture needle, non absorbable surgical suture, disposable medium single, medical absorbent gauze pad Disposable sterile rubber surgical gloves, medical gauze bandage, self-adhesive wound protection patch, disposable sterile maternal bleeding calculation towel, shoe cover, medical sterile protective cover.

[product performance] 1. All accessories in the bag should be free from damage, stain and impurity; the sewing parts should be sewn firmly, with uniform, straight needle size, no crease, no skipping, stitching and leakage; the folding parts should be folded neatly; the needle spacing of stitches should be no less than 8 stitches within 3cm. 2. The operating clothes shall be free from mildew, damage, stain and impurities; the stitched surgical clothes shall be uniform, straight, without creases, stitch skipping, stitching and leakage; the hot pressed surgical clothes shall be hot pressed evenly, flat, without wrinkle or leakage; the chest film (if any) shall be made of coated nonwovens, plastic films or nonwovens, and the size shall not be less than 40cm × 60C m. Tolerance: ± 10cm; if coated nonwovens are used, they should not be less than 35g / m2, and the film should be flat, without bubbles and separation; if there is a plastic film at the sleeve, the plastic film should not be damaged, and the thickness of the plastic film should not be less than 0.01mm; the plastic film should not be damaged, the thickness of the plastic film should not be less than 0.01mm; the specification of the nonwovens used should not be less than 20g / m2; the longitudinal breaking strength should be greater than or equal to 13N, The transverse breaking strength should be greater than or equal to 8N; the coated nonwovens used for surgical sleeves should not be less than 35g / m2, and the film should be flat, without bubbles and separation; there should be plastic film at the sleeve, and the plastic film should not be damaged, and the thickness of the plastic film should not be less than 0.01mm. (if any); the sewing or hot pressing part shall be firm, and the firmness shall be no less than 10N; the breaking strength of the joint between each tie and the operating clothes shall be no less than 10N; the performance of the operating clothes shall meet the requirements of Table 2; when the suture 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 substances in water shall not exceed 0.50%. 3. Disposable medical pads should be qualified products with medical device registration certificate. 4. Disposable pore towel should be a qualified product with medical device registration certificate. 5. Disposable treatment towel should be a qualified product with medical device registration certificate. 6. The coated nonwovens used for trouser legs shall not be less than 30g / m2, and the film shall be flat, free of bubbles and separation; the trousers legs made by hot pressing shall be hot pressed and flat without leakage pressure, and the breaking strength shall not be less than 5N. 7. Disposable medical rubber inspection gloves should be qualified products with medical device registration certificate. 8. Disposable masks should be qualified products with medical device registration certificate. 9. Disposable caps should be qualified products with medical device registration certificate. 10. Medical absorbent gauze should be qualified products with medical device registration certificate. 11. The umbilical cord should be clean and pollution-free, sewn firmly, without thread loss and jumper phenomenon; the length should not be less than 42cm; the weight after absorbing water should not be less than 8 times of its own weight. It is required that the cotton and viscose gauze should meet the requirements when tested according to 5.5 of YY 0331-2006 standard; the sinking time should not exceed 10s when tested according to 5.9 of YY 0331-2006 standard; the solution should not show pink when tested according to 5.3 of YY 0331-2006 standard. The formaldehyde content of cotton cloth should be less than or equal to 20mg / kg; the pH value of cotton cloth should be 4.0-7.5; if spunlaced nonwovens are used, 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 peel strength of adhesive tape should not be less than 10N, the adhesive adhesion of medical adhesive should not be more than 2.5mm, and the peel strength should not be less than 1.0n/cm. 12. All sides of umbilical cord clamp should be smooth, without burr, and the closure should be flexible and firm. 13. If degreasing cotton gauze is used for medical absorbent gauze used in umbilical cord cap, the cotton fiber shall meet the requirements of identification test a, B and C; if degreasing cotton viscose blended gauze is used, cotton fiber shall meet the requirements of identification test a and C; viscose fiber shall meet the requirements of identification test B; product luster shall meet the requirements of identification test D; no solution shall show pink; only a small amount is allowed occasionally There are isolated foreign fibers; cotton and viscose gauze should meet the requirements; the number of yarns per 100 mm should meet the requirements given in Tables 1 and 2 of YY 0331-2006; the mass per square meter (in gram) should meet the requirements in Tables 1 and 2 of YY 0331-2006; the breaking force per 50 mm (in Newtons) should meet YY The requirements of Table 1 in the 0331-2006 standard should not exceed 10S; the total amount of soluble matter in the ether should not be greater than 0.50%; the height of the surfactant foam for the test solution should not exceed 2m; the total amount of soluble matter in the water should not be greater than 0.50%; the solution should not be blue, purple, light red or light brown; the color of the obtained liquid should not be deeper than that of the control fluid Y5 and GY6 specified in Appendix A; defatted cotton yarn. The results showed that the weight loss of the fabric should not be greater than 8.0%; the mass loss of the absorbent cotton viscose blended gauze should not be greater than 11.0%; the total sulfate ash should meet the requirements of Table 3 in YY 0331-2006 standard; the suture should not show strong blue fluorescence; the total amount of soluble substances in water should not exceed 0.50%. 14. The performance of umbilical cord should meet the requirements for qualified products in GB / T 6836-2007. 15. Medical cotton swabs should be qualified products with medical device registration certificate. 16. Medical cotton ball should be a qualified product with medical device registration certificate. 17. The disposable medical wrapping cloth 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; if the wrapping cloth is made by hot pressing, the hot pressing part should be firm without cracking. 18. Medical suture needle should be qualified product with medical device registration certificate. 19. Non absorbable surgical suture should be qualified product with medical device registration certificate. 20. The single use list should be the qualified product with medical device registration certificate. 21. Medical absorbent gauze pad shall be qualified product with medical device registration certificate.

22. Disposable sterilized rubber surgical gloves shall be qualified products with medical device registration certificate. 23. Medical gauze bandages should be qualified products with medical device registration certificate. 24. The self-adhesive wound protection patch should be a qualified product with medical device registration certificate. 25. Disposable sterile maternity bleeding calculation towel pad should be a qualified product with medical device registration certificate. 26. The shoe cover can be made of nonwovens, coated nonwovens or plastic film, and the appearance shall be free of holes; the shoe cover made by hot pressing shall be flat and flat without leakage, and the breaking strength shall not be less than 5N; the elongation ratio of elastic band shall be 1:2.2-1:3.0; the tensile elastic recovery rate shall be 75.0%; the specification of nonwovens used shall not be less than 20g / m2; the longitudinal breaking strength shall be greater than or equal to 17.0n, The transverse breaking strength should be greater than or equal to 3.0N; the coated nonwovens should be no less than 30g / m2; the film should be flat, without bubbles and separation; the plastic film used should not be damaged, and the thickness of the plastic film should not be less than 0.01mm. 27. Medical sterile protective cover shall be qualified product with medical device registration certificate. 28. The name, specification and quantity of items configured in the production package shall meet the requirements of Table 1 and table 2. 29. The delivery package should be sterile. 30. The ethylene oxide residue should not be more than 5ug / G after sterilization with ethylene oxide.

[scope of application] it is suitable for clinical delivery in obstetrics and Gynecology of medical institutions.

[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 specifications and models of the patients, and open the package after confirming that the outer package is in good condition.

2. According to the needs of surgery, the accessories can be used.

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.