510K Approved Antimicrobial Silver Alginate Dressing

• Customization: Available
• Type: Surgical Supplies Materials
• Material: Silver Calcium Alginate
• Model NO.: SAD1090
• Ethylene Oxide Sterilization: Gamma
• Quality Guarantee Period: 3 Years
• Group: All
• Logo Printing: Customized
• Name: Silver Alginate Dressing
• Furthures: Antibacterial
• Lead Time: 25 Days
• Furthure1: OEM
• Furthure2: Cavity Wounds;Exuding Wounds;Burn Wounds
• Furthure3: Antibacterial Action
• Keyword: Silver Alginate Dressing
• Transport Package: 1 PC/Pouch
• Specification: 5x5cm, 10x10cm, 15x15cm, 30x2cm
• Trademark: OEM brand
• Origin: Cn
• HS Code: 3006700000
• Production Capacity: 5, 000, 000 PCS/Year

Product Description

Foryou Medical

• The sole manufacturer for Silver foam dressing with 510K approval in China
• The first manufacturer in China for getting 510K for silver algiante dressing
• Producing the best quality silicone foam dressing in China
• The No. 1 advanced wound dressing and hemostatic medical products manufacturer with the most Comprehensive and systematic product-line

Product Description
Silver Alginate Dressing is a non-woven pad composed of calcium alginate and silver particles. The silver content is 50µg/100 cm2. The silver particles are in the form of encapsulated metallic silver, which is very stable and won't be oxidized even on exposure to light.

LUOFUCON® Silver Alginate Dressing is proved to have broad spectrum antibacterial effect , based on in vitro laboratory testing.


 
1. Silver Release
Figure1 shows that Silver Alginate Dressing leaches about 57% of the total silver during the first 24 hours, and 30%, 24% of its total silver during 24-48, 48-72 hours, respectively.
The release profiles indicates that the release of silver from the dressing is well controlled.
 
Note:
Two pieces of the dressing in the size of 10 x 10 cm were used in this test. The test was performed by China National Analytical Center at Guangzhou.
 
2. Antibacterial Activity
2.1 Comparative Test
One representative Gram-positive bacteria(Staphylococcus aureus) and one representative Gram-negative bacteria(Pseudomonas aeruginosa) were tested under AATCC 100-2004.
Figure 2 and Figure 3 show Silver Alginate Dressing has four log reduction (99.99%)for both organisms, the other two products only have three log reduction (99.9%).
 
Figure 2 Log Reduction - Staphylococcus aureus Figure 3 Log Reduction - Pseudomonas aeruginosa
Note: Comparison 1 and 2 are other silver alginate dressings in the market. The test was performed by our own laboratory.
 
2.2  Antibacterial Effectiveness Test
AATCC 100-2004 only specifies the use of one Gram-positive and one Gram-negative bacteria. However, we tested six clinical-relevant bacteria ( 3 Gram-positive and 3 Gram-negative bacteria) for the evaluation of antibacterial effectiveness.
 

Test Organism		Test Method
Enterococcus faecalis	ATCC 29219	Dressing specimens and controls were tested under simulated use conditions for seven days. During this time, test articles were kept moistened daily with phosphate buffered water containing 10% Fetal Bovine Serum to simulate daily use. The antibacterial activity testing was performed with an inoculum challenge of more than 106 CFU total.
Escherichia coli	ATCC 8739
Klebsiella pneumoniae	ATCC 4352
Pseudomonas aeruginosa	ATCC 9027
Staphylococcus aureus	ATCC 6538
Streptococcus pyogenes	ATCC 19615

 
Figure 4 Antibacterial Effectiveness(GLP Study)
 
At day-1, results show LUOFUCON® Silver Alginate Dressing has bacteria reduction of at least four log reduction for all six test organisms;
 
At day-7, bacteria reduction for all the organisms is at least two log reduction(data in table 1 and table 2).
 
Note:The test was performed under Good Laboratory Practice regulations, by WuXi AppTec, Inc.(Address :1265 Kennestone Circle, Marietta, GA 30066).
 
Based on the test results, LUOFUCON® Silver Alginate Dressing has broad spectrum antibacterial effect for Gram-positive and Gram-negative bacteria.
 
 Table 1: 1 Day Antibacterial Effectiveness

	1 Day
	Replicate 1	Replicate 2	Replicate 3
Staphylococcus aureus	>4.0	>4.1	>4.1
Streptococcus pyogenes	>4.4	>4.4	>4.3
Enterococcus faecalis	>4.3	>4.2	>4.3
Escherichia coli	>4.2	>4.2	>4.13
Klebsiella pneumoniae	>4.1	>4.0	>4.1
Pseudomonas aeruginosa	>4.1	>4.1	>4.1

 
 Table 2: 7 Days Antibacterial Effectiveness

	7 Day
	Replicate 1	Replicate 2	Replicate 3
Staphylococcus aureus	>4.0	>4.0	>4.0
Streptococcus pyogenes	>4.1	>4.1	>4.1
Enterococcus faecalis	2.1	1.6	2.6
Escherichia coli	>4.3	>4.3	>4.3
Klebsiella pneumoniae	>4.2	>4.2	>4.2
Pseudomonas aeruginosa	>4.0	>4.0	>4.0

Related Products
.Borber Silicone foam dressing
.PU medical foam dressing
.Hydrogel wound dressing
.Silver alginate dressing





Certificates    
1  CE certificate
2. ISO13485
3.  FDA 510K
4. CFDA

Our Company Advantages
1.     Group company more than 40,000 staffs
2.     FDA approved company
3.     11 years OEM&ODM experience
4.     Strong R&D team,more than 40 staffs
5.     Professional and strict quality control team more than 20 staffs
6.     Have own core technology
7.     Others

Company introduction

 

 

For you, for us, for life. Welcome to Huizhou Foryou Medical Devices Co., Ltd. Unlike other typical Chinese OEM companies, Foryou Medical is a manufacturing enterprise who not only focuses on up-to-date Research & Development, but also dedicates in excellent Quality Control.

LUOFUCON Advanced Wound Care Dressing, SUNTOUCH Hemostatic Products and FORUSORB Bioabsorbable Materials, these three production lines make us stand out from the competition. Each line has more than 10 types of products with various sizes and specification.

We are very proud to present that we are the first FDA 510K receiver of Silver Alginate Dressing and Silver Foam Dressing, one of the top Absorbable Gauze manufacturers with CFDA Class III. Composite Wound Dressing, such as Silver Silicone Foam Dressing and other brilliant products are on their way to provide one-stop solution for you.

During these years, we have successfully obtained ISO13485, FDA 21CFR820, MDD93/42/EEC, KGMP and ISO 9001. What's more, zero observation through FDA and high approval with KFDA, CFDA and our clients audits strengthen our capability to supply you with high quality products and service.

We are one susidiary of Asian 500 Most Influential Brands, Foryou Group. But it's you who make us shine brightly.

For you, For us, For life. Welcome to inquire us to start your wonderful experience.