enterprise:Xinxiang qiangsheng medical equipment co. LTD
cellphone:18568235005fax:0373-8962789
URL : www.hnqiangsheng.com
Address: dingluan town industrial zone, changyuan county, xinxiang city, henan province
Welcome to xinxiang qiangsheng medical equipment co., LTD.!
[product name] disposable sterile suture dressing change package
[structure and composition] this product is composed of hole towel, disposable wrap cloth, medical gauze block, disposable medical rubber inspection gloves, medical tweezers, sewing
Combination needle, non - absorbent suture, medical cotton ball, article box composition.
】 【 specifications Ⅰ for dressing, Ⅱ for stitching.
1) disposable sterile suture dressing bag has clean and complete appearance, clear writing, no stain or damage, and firm heat sealing.
2) the performance of nonwovens used in the cave towel and covering cloth shall comply with the provisions of FZ/ t64005-2011.
3) the size and performance of rubber inspection gloves should comply with the provisions of gb10213-2006, without water leakage and elongation before aging
It shall not be less than 650% and the minimum breaking force shall not be less than 7.0n.
4) the appearance of medical tweezers should be smooth, no edge, burr, crack.
5) the performance of gauze blocks shall comply with the provisions of YZB/ yu 0081-2008.
6) the performance of cotton balls shall comply with the provisions of YZB/ yuchang 0042-2011
7) the box shall be made of PS plastic sheet. The sides of the box shall be smooth and without burrs.
8) the properties of suture needles shall comply with the provisions of yy0043-2005.
9) the performance of the suture line shall comply with the provisions of yy0167-2005.
10) sterile.
11) residual ethylene oxide: no more than 10 g/g.
[scope of application] suitable for clinical wound treatment (dressing change or suture).
[method of use] before use, please check whether the package is in good condition and whether the sterile time limit is within the validity period.
According to the individual conditions of patients, different debridement, dressing change, suture and other treatment and nursing methods should be selected.The use of this product should be strictly followed
Follow the standard operating instructions for changing or stitching.
1) the operator should first wash hands in seven steps to disinfect.
2) open the outer packing according to relevant regulations, take out the package, and open it in the order of covering.
3) take out disposable rubber inspection gloves and put them on the right and left hands according to relevant regulations.
4) apply a plastic tweezer clip to the external dressing of the wound.
5) take another pair of tweezers to hold the cotton ball and dip in different debridement liquid or disinfectant for debridement and disinfection.(the two
Tweezers are not interchangeable)
6) if suture is needed, the operator should prepare a set of sterile needle holding pliers in advance.
7) take out the suture needle and suture line for inspection, and conduct the suture operation according to the relevant suture operation specifications.
8) disinfect the wound again, apply gauze and then wrap it up.
[production date] see package seal or bag qualification certificate.
[sterilization date] see package seal or bag qualification certificate.
[expiration date] see package seal or bag certificate.
[matters needing attention, warnings and tips]
1) check the package before use. Do not use it if the package is damaged.
2) this product has been sterilized by ethylene oxide, and the sterile period is two years.
3) this product is only for one-time use and will be destroyed according to relevant regulations after use.
[storage method] it should be stored in a ventilated, clean and cool place with relative humidity no more than 80%.Avoid fire source, toxic, volatile and decay
Contact with corrosive substances.
Appendix 1: list of components for disposable sterile suture dressing change kits
component name | Component source | Outsourced component state | Component manufacturing process and its impact on component safety and effectiveness | |||
Whether the sterilization | Packaging, marking | expiry date | Listing approval information | |||
infantees | produced | / | / | / | / | no |
drapes | produced | / | / | / | / | no |
cotton ball | produced | / | / | / | / | no |
gauze piece | produced | / | / | / | / | no |
Rubber inspection gloves | outsourcing | no | Individually packed, aubon | 2 years | Food and drug administration instrument (quasi) no. 2660089, 2009 | no |
medical forceps | outsourcing | no | Boxed, tented | 2 years | 410728100007373(2012年3月) | no |
medical suture needle | outsourcing | no | Boxed, bing xiong | no | Anhui food and drug administration armed (quasi) zi 2011 no. 2010054 | no |
Nonabsorbable surgical suture | outsourcing | no | Bag, source health | no | Su food and drug administration weapon (quasi) no. 2650202, 2007 | no |
Items box | outsourcing | no | Packed and transported | no | 410728100007373(2012年3月) | no |
[address] guandong, dingluan town, changyuan county
[after-sales service unit] xinxiang qiangsheng medical equipment co., LTD
[address] guandong, dingluan town, changyuan county
[production address] kanto, dingluan town, changyuan county
[fax: 0373-8962222] 0373-8962789
h.nqs@163.com
[specification preparation date] December 25, 2014