FDA 510K Silver Ion Wound Dressing Ulcer Dressing

• Customization: Available
• Type: Surgical Supplies Materials
• Material: Calcium Alginate
• Model NO.: SA100100
• Ethylene Oxide Sterilization: Gamma
• Quality Guarantee Period: Three Years
• Group: Adult
• Logo Printing: With Logo Printing
• Size: 2.5X30cm,10X10cm,12.5X12.5cm,5X5cm
• Color: Light Yellow
• Certificate: FDA 510K
• OEM: Available
• Validity: 3years
• Transport Package: Paper-Film Pouch
• Specification: 10x10cm, 5x5cm, 12.5x12.5cm
• Trademark: Luofucon
• Origin: China
• HS Code: 3005901000
• Production Capacity: 5000000 PCS Per Year

Product Description

Description
Mainly sodium alginate, calcium alginate and silver particles
LUOFUCON® Silver Alginate Dressing is made of natural fibers derived from seaweed through a series of special process. It is designed to be highly, fast absorbent. The dressing absorbs exudates and forms a gellike covering over the wound, maintains a moist environment for wound healing. The gel-like surface also keeps the dressing from adhering to the wound so it is painless removal. Also, LUOFUCON® Silver Alginate Dressing can restrain the bacteria growing, and reduce infection. LUOFUCON® Silver Alginate Dressing has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae.

Indications
Moderately to heavily exuding partial to full thickness wounds, including:
1. Trauma wounds
2. Pressure ulcers
3. Diabetic ulcers
4. Leg ulcers
5. Graft and donor sites
6. Post-operative surgical wounds

Contraindications
1. Do not use LUOFUCON® Silver Alginate Dressing on patients with known sensitivity to silver.
2. LUOFUCON® Silver Alginate Dressing is not intended for use on third-degree burns.

Product Information:

Antibacterial Agent:	Silver particles
Active Against Pathogens:	Gram positive and Gram negative bacteria
Spectrum of Activity:	Board spectrum antibacterial effect for Gram positive and Gram negative bacteria
Concentration on the device:	Each dressing contains 50ug/100cm2 silver particles

In Vitro Study Results:
The device is non-irritating, non-sensitising, non-cyctotoxic and biocompatible in a wound environment. Thedevice is tested for antibacterial activity till day-1. The device has board spectrum antibacterial effect for Gram positive and Gram negative bacteria.

Bacterial	Staphylococcus aureus ATCC 6538	Streptococcus pyogenes ATCC 19615	Enterococcus faecalis ATCC 29212
24 Hour %Reduction	>99.99%	>99.99%	>99.99%

Bacterial	Escherlchia coli ATCC 8739	Klesiella pneumonlae ATCC 4352	Pseudomonas aeruginosa ATCC 9027
24 Hour %Reduction	>99.99%	>99.99%	>99.99%

Instructions for Use
1. Clean the wound with sterile saline water and dry the surrounding skin gently.
2. Choose the right size of dressing to cover the wound according to wound area.
3. Cover and secure the LUOFUCON® Silver Alginate Dressing with a secondary dressing.
4. Dressing change frequency will depend on patient condition and the level of exudates. Initially it may be necessary to change the dressing every 24 hours. When the exudates reduce, the frequency may be slowdown.
5. Gently remove the secondary dressing. If the wound appears dry, saturate the dressing with sterile saline water prior to removal.