[product name] sterile gauze block.
Model: type I, type II; Specifications: length (1-300) cm x width (1-300) cm- layer (1-50) P, specific specifications are detailed in the product package.
[name of registrant] henan jianqi medical equipment co. LTD.
The dingluan industrial zone in changyuan county.
[contact number] 0373-8690789.
[after-sales service unit] henan jianqi medical equipment sales co., LTD.
[name of production enterprise] henan jianqi medical equipment co., LTD.
The dingluan industrial zone in changyuan county.
[production address] dingluan industrial zone, changyuan county.
[contact information] 0373-8690789.
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.
[registration certificate no.] yu ordnance note 20172640724.
[technical requirements no.] yu ordnance note 20172640724.
[structure and composition] this product is made of medical absorbent gauze.
[product performance] 1. The gauze block should be folded and flat, without the appearance of the naked edge (except for the edge of gauze), no odor, mildew, impurities, stains, holes and defects; Gauze piece of X-ray detectable components without fracture, fall off, jump line phenomenon (only applicable to Ⅱ type gauze piece). 2. The actual size of the gauze block and the tolerance of nominal specification are plus or minus 10%. 3. The cotton fiber should be in accordance with the requirements of the identification test A, B and C according to the test of YY 0331-2006. According to the test of YY 0331-2006, cotton fiber should meet the requirements of identification test A and C. The viscose fiber should meet the requirements of identification test B; The luster of the product shall meet the requirements of the identification test D; The solution should not be pink; The warp fiber should be all or almost all cotton, and the weft fiber should be all or almost all typical cotton fibers. Check the warp and weft fibers, occasionally a small number of isolated foreign fibers exist; Only the microscopic brown and purple fluorescence and a small amount of yellow particles should be used. In addition to a small amount of isolated fiber, should not show strong blue fluorescence; The number of yarn per 100mm should meet the requirements of table 1; The quality of each square metre (in grams) should meet the requirements of table 1; The minimum breaking force per 50mm (in newtons) should meet the requirements of table 1; The sinking time shall be no more than 10S; The total amount of soluble in ether should not be greater than 0.50%; After 300S, the surface active substance foam should not exceed 2mm. The total amount of soluble in water should not be greater than 0.50%; The solution should not be blue, purple, light red or light brown; Get the color of the liquid should be deep in appendix A of regulations on the control of the liquid Y5, GY6 or reference solutions according to the following methods: 3.0 mL to primary blue solution with 7.0 mL of hydrochloric acid solution (mass concentration of 10 g/L hydrochloride), using hydrochloric acid solution (mass concentration hydrochloric acid of 10 g/L) 0.5 mL of the solution will be diluted to 10.0 mL. The quality loss of absorbent cotton gauze should not be greater than 8.0%; The total amount of sulphate ash should meet the requirements of table 2. 4, X-ray detectable components shall be not less than 55% of barium sulfate content of material or other have the same X-ray opaque materials, the material should not fall off fiber, should not affect dressing softness; The X-ray detectable component can be detected from the gauze package, and its quality should meet the following requirements: single wire: not less than 0.5 g/m; Multifilament: no less than 0.28 g/m; The imaging of the samples should be significantly lighter than the background in accordance with the standard yy0594-2006 appendix B test. 5. The gauze should be sterile. 6. The gauze block is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10 mu g/g.
[scope of application] for clinical nursing and moisture absorption.
Contraindication: no absolute contraindication.
1. This product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.
2. See packaging seal or label on the production batch number, and the sterilization date is in the outer packing box.
3. This product is sterilized by ethylene oxide.
[use method] 1. Select the applicable specifications and model, and then open the package after the outer packing is in good condition.
2. To clean the skin, mucous membrane, wound surface and moisture absorption according to the clinical patients' wound or fluid exudation, it can also be used to protect the wound surface with the commonly used drugs of wound care.
3. After the product is finished, it should be treated with medical waste to avoid pollution.
[storage method] 1. This product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain and snow.
2. Handle gently in handling and avoid violent collision;
3. The product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment.
[production date] see packaging seal or label.
Expiry date: see packaging seal or label.
[label, package logo]
[specification preparation date] August 21, 2017.