[product name] disposable surgical clothing.
[specifications] type i, type ii.
[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 mark 20172640086.
[technical requirements no.]
[structure and composition] the operating garment consists of the predecessor, the back body, the sleeve, and the belt.
[product performance] 1. the operation clothes should be free of mildew, no damage, no stains, no impurities; the needle code should be uniform, straight, no crease, no jump needle, open line and leak. the hot pressing of the operating clothes should be uniform, straight, no wrinkle, no leakage pressure.
2. the non-woven booker should not be less than 20g/m2; the longitudinal fracture strength of nonwoven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. 3. no less than 24 stitches per 10cm. 4. if there are chest films in the chest of the operating garment, it should be no less than 40cm by 60cm for non-woven fabric, non-woven fabric or plastic film. non-woven fabrics should not be less than 20g/m2; the longitudinal fracture strength of nonwoven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. the film should not be less than 35g/m2, and the film should be flat, free of bubbles and separate phenomena. the plastic film should not be damaged, the thickness of the plastic film should not be less than 0.01mm; should not be damaged, the thickness of plastic film should not be less than 0.01mm. 5. the surgical sleeves should be no less than 35g/m2, and the film should be flat, free of bubbles and separate phenomena. plastic film, plastic film should not be damaged, plastic film thickness should not be less than 0.01mm (if any). 6. the sewing or hot pressing should be strong, and the strength should not be less than 10n. the rupture strength of each lacing joint should not be less than 10n. 7. the performance of the operating garment should meet the requirements of table 2. 8. the stitches should not show strong blue fluorescence when testing a test in appendix d of yy 0594-2006. the total amount of soluble in water should not exceed 0.50%. 9. the operating coat should be sterile. 10. the operation garment is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10ug/g.
[scope of application] for surgical personnel to wear, reduce the infection source to the patient surgical wound surface to prevent postoperative wound infection; it can also reduce the risk of transmission of the infection from the blood or body fluids to the surgical staff.
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. after gently spreading the operating coat, put your arms into your sleeve and tighten the collar band and waist belt.
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] february 7, 2017.
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