[product name] medical absorbent gauze

[specification and model] model: type I and type II; specification: length (1cm-300cm) × width (1cm-300cm) - layer (1p-50p). Please refer to the small package for specific specifications.

[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 20172640057

YZ [201726407] technical requirements

[structure and composition] this product is made of medical absorbent gauze.

[product performance] 1. The product should be folded and flat, without burr exposure (except for the side drawing gauze), odorless, mildew, impurities, stains, holes; medical degreasing gauze block can be detected by X-ray, and the components shall be free of breakage, falling off and jumper (only applicable to type II gauze block). 2. The tolerance between actual value and nominal value is ± 10%. 3. The cotton fiber of degreasing cotton yarn cloth should be flat ribbon, 10 μ m to 40 μ m in width, thickened at the end and irregular shape of cavity; the fiber should be purple; the fiber should not be dissolved; there should be no solution showing pink; the warp fiber should be all or almost all cotton fiber, and the weft fiber should be all or almost all typical cotton fiber. In the inspection of warp and weft fibers, a small amount of isolated foreign fibers may occasionally exist; only a small amount of brown purple fluorescence and a small amount of yellow particles should be observed. In addition to a small number of isolated fibers, no blue fluorescence should be observed; the yarn count per 100mm should meet the requirements of Table 1; the quality per square metre (in grams for units) should meet the requirements of Table 1; the breaking force per 50mm (in Newton) should meet the requirements of table 1; the subsidence time should not exceed 10S; the total amount of soluble matter in ether should not be greater than 0.50%; after 300S, the surfactant foam for test solution. The results showed that: the height of the solution should not exceed 2mm; the total amount of soluble substances in water should not be more than 0.50%; the solution should not show blue, purple, light red or light brown; the color of the liquid obtained should not be darker than the reference solution Y5, GY6 specified in Appendix A or the reference solution prepared according to the following methods: add 7.0ml hydrochloric acid solution (mass concentration of 10G / L hydrochloric acid) into 3.0ml primary blue solution, and use hydrochloric acid solution 0.5ml of the above solution was diluted to 10.0ml (hydrochloric acid with mass concentration of 10G / L); the mass loss of absorbent cotton gauze should not be greater than 8.0%; the total sulfate ash content should meet the requirements of Table 2. 4. The x-ray detectable component shall be made of barium sulfate material with the content of no less than 55% or other materials with the same X-ray impermeability. The material shall not shed fiber, and shall not affect the softness of dressing or provide raw material inspection report. The x-ray detectable component shall be gently extracted from the gauze bag and its quality shall meet the following requirements: monofilament: no less than 0.5 The image of the sample should be obviously shallower than the background when tested according to Appendix B of yy0594-2006. 5. Gauze block is divided into sterile and non sterile types; gauze block supplied in sterile form shall be sterile. 6. The residual ethylene oxide content of gauze should not exceed 10 μ g / G after sterilization with ethylene oxide.

[scope of application] it is used for clinical wound protection and moisture absorption.

[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. According to the wound surface or fluid exudation of clinical patients, the clinical operation of cleaning skin, mucous membrane, wound surface and moisture absorption was carried out.

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.