- Model NO.: LW-H-009
- Feature: Disposable
- Ethylene Oxide Sterilization: Radiation
- Group: All
- FDA 510k: Cfda Class III
- ISO13485: Stop Bleeding Fast
- Trademark: Suntouch
- Origin: Huizhou, Guangdong, China
- Material: Oxidize Regenerate Cellulose
- Certification: CE, FDA, ISO13485, Cfda
- Application: Hospital
- Logo Printing: Both Ok
- CE: Absorbable
- Laparotomy: Hemostatic Gauze
- Specification: 12 pcs per package and customization
- HS Code: 3005901000
We Foryou medical company start to do experiment from 2008 till 2014, for our Suntouch hemostatic gauze, from mouse, rabbit, pig, monkey and human, We observe all the process from distribution, decomposing, soluble, dissolution, excrete-complete process. We have a complete systematic experiment basis.
We applied CFDA classIII from Oct 2014 and passed CFDA classIII on 16th Jan 2015. And we are comply with FDA 510K and CEIIa. And we passed ISO13485. So we have enough certificates.
1, Absorbency: Suntouch Hemostatic Gauze, could be soluble in 10-15 seconds, completely absorbed in 1 hour, no any inclusion.
- Suntouch Hemostatic Gauze, for extracorporeal hemostasis, 70 seconds to achieve hemostasis effect, compare with other similar products need 80 seconds and 100 seconds; for hepar wound surface, 50 seconds to achieve hemostasis effect, compare with other similar products need 60 seconds and 70 seconds.
- Suntouch Hemostasis success rate: 3 minutes, Suntouch 94.1%, compare with others 80.9%; 5 minutes, Suntouch 100%, others 97.1%.
3, Degraded: Suntouch Hemostatic Gauze could be completely excreted in 14 days, 90% of them could be excreted by urine, 10% of them could be excreted by excrement, in molecule ancestor form.
In addition: Ours PH is 7, compare with other similar product PH 3, this would bring some inflammation, but we would not; According to our experiment, we could say Suntouch Hemostatic Gauze has no effect for liver function and renal function, it is safe.
We are Standard setters for Soluble Gauze in China.