CE Surgiclean Absorbable Gauze of Oxidized Regenerated Cellulose
CE 2292
[Product Name]
Absorbable Gauze of Oxidized Regenerated Cellulose
[Composition]
100% oxidized regenerated cellulose
[Description]:
Absorbable gauze of oxidized regenerated cellulose (hereafter called Gauze) is made from regenerated cellulose as raw material, which is oxidized and woven into gauze, and will degrade in the body without residual material. The product ingredient is 100% oxidized regenerated cellulose. It is white with a pale yellow fabric and has a faint, caramel-like aroma. This product is applied to the surface of the wound, with hemostatic efficacy. The product is shaped by a layer of medical packaging paper, sealed in an aluminum-plastic bag, and then packed in a paper plastic bag. Finally, put the product in a small box. This product is sterilized by irradiation.
[Principle of action]
The Gauze contains carboxyl groups which can absorb erythrocytes, adhere to platelets and activate the clotting systems, thereby promoting hemostasis. After the Gauze has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a hemostatic adjunct in the control of local haemorrhage. Usually, the bleeding is stopped within minutes.The Gauze degradation in vivo begins after hemostasis, and its absorption rate depends on multi factorsincluding the dose used, the site being treated, and the degree of blood permeation.
[Degradation]
After implantation in vivo, the product can be degraded and absorbed by 28 days.
[Indications]
As a supporting hemostatic device, this product is suitable for various surgical procedures (except dental, cardiovascular, neurosurgery, ophthalmology, and urology). It can help control the bleeding of capillaries, veins, and small arteries where bleeding can't be well controlled by traditional methods like ligation.
[Patient target groups]
Suitable for people who need to stop bleeding during surgical operations, such as liver bleeding, ear nose and throat bleeding and femoral artery bleeding, etc. However, the product is not recommended for children, pregnant women, and breastfeeding females.
[Treatment Procedure]
The doctors have to inform the patients about the indications, expected result and, duration of effect, contraindications, precautions, warnings and potential adverse events before treatment. Doctors shall also discuss all potential risks of Gauze with their patients prior to treatment and ensure that patients are aware of the signs and symptoms of potential complications.
[Dosage and Methods of Application]:
Check the integrity of sterile container, do not use if the package is broken.
Remove the gauze from the aluminum-plastic bag, cut out a suitable and minimal size, place the cutted gauze on the hemostatic site and press firmly until hemostasis. The quantity is determined according to the bleeding site and the amount of bleeding.
It has been reported that the gauze can be used in the following areas of surgery(except dental, cardiovascular, neurosurgery, ophthalmology, and urology): appendectomy, breast surgery, hernioplasty, gastric resection, operations to the throat and nose, liver and gall bladder operations, gynaecological operations, thyroid operations, treatment of superficial injuries, and so on.
[Precautions]:
1. Do not use if the package is broken.
2. Do not remove the Gauze before bleeding completely stops.
3. Since absorption of the product could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.
4. Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient.
5. Use of this product near large and medium blood vessels may result in vascular embolism.
6. This product can promote blood coagulation at the site of use. Excessive use of this product may cause thrombosis at the site of use.
7. Users must obtain relevant professional physician qualifications in medical institutions officially approved by the state.
[Warnings]:
1. Sterile, for single use, recycle not permitted.
2. This product is a supporting material to conventional haemostasis methods; it cannot replace suture and ligature, etc.
3. Applying the Gauze in a contaminated wound without drainage may lead to complications. lt should be avoided.
4. This product has excellent water absorption, keep away from liquids before using.
5. This product has a low pH; do not mix/use with enzyme based hemostatic agents.
6. Remove any excess after haemostasis is achieved in order to minimize the possibility of foreign body reaction.
7. This product must not be used in conjunction with a blood recovery system, as product fragments may pass through the filter causing blockages in the blood recovery system or the patient's vasculature.
8. The product must not be used in conjunction with a methyl methacrylate adhesive for prosthetic orthopedic devices, which may reduce the strength of the adhesive.
9. In case of any serious incident related to the device, it shall be reported to the manufacturer, distributor,EU authorised representative and the competent authority. If there are any complaints occur in the process of use, you can directly feed back to the distributor or visit www.singclean.net to feed back to the manufacturer.
10. Excess gauze after hemostasis has been achieved at the end of treatment should be discarded immediately and not reused. Dispose of in a required medical waste disposal area.
[Contraindications]:
1. The Gauze should not be used in bone defects.
2. The Gauze should not be in stuffing, unless it is to be removed after haemostasis is achieved. The gauze should be removed by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.
3. The Gauze should not be used to control haemorrhage from large arteries.
4. The Gauze should not be used on non-haemorrhagic serous oozing surfaces, since body fluids are different from whole blood.
5. The Gauze should not be used in neurosurgery, ophthalmology, and urology.
6. The Gauze should not be used to patients allergic to viscose filaments.
[Adverse reactionsj:
1. It has been reported that the use of oxidized regenerated cellulose products may cause fluid cysts or foreign body reactions.
2. It has been reported occasionally that the use of oxidized regenerated cellulose products may cause “burning" and "stinging" sensations, or sneezing symptoms after nasal surgery, which may be attributed to the low pH of the products.
3. It has been reported that use of oxidized regenerated cellulose products may prolongate drainage time in cholecystectomies.
4. It has also been reported that the use of oxidized regenerated cellulose products may cause stinging" sensations when the products was applied on surface wounds (varicose ulcerations and donor sites). If the above symptoms last three days and have no release, please search a medical support immediately.
[Sterilization]:
Method of sterilization is electron beam radiation.
[Specifications]:
2cm*3cm/pc, 3cm*5cm/pc, 5cm*5cm/pc, 5cm*7.5cm/pc, 5cm*8cm/pc, 5cm*10cm/pc, 7cm*8cm/pc, 5cm*25cm/pc, 5cm*30cm/pc, 5cm*35cm/pc, 10cm*10cm/pc, 10cm*15cm/pc, 10cm*20cm/pc, 22.5cm*22.5cm/pc, 30cm*30cm/pc, 30cm*50cm/pc
[Storage]:
lt should be stored in clean, dry, ventilated and non-corrosive environment, and temperature of 5℃-20℃.
[Shelf Life]
2 years.
Latest version 8.07.04.0309-A2 Issued Date:2026-05-27
