• Wound Care High Absorbent Silver Calcium Alginate with CE/ISO13485/FDA 1

Wound Care High Absorbent Silver Calcium Alginate with CE/ISO13485/FDA 1

Type: Surgical Supplies Materials
Material: Silver Calcium Alginate
Ethylene Oxide Sterilization: Gamma
Quality Guarantee Period: 3 Years
Group: All
Logo Printing: Customized
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Rating: 5.0/5
Manufacturer/Factory, Group Corporation

Basic Info.

Model NO.
SAD1112
Name
Silver Alginate Dressing
Specification
5X5cm, 10X10cm, 15X15cm, 30X2cm, 5x5cm, 10x10cm, 15x15cm, 30x2cm
Color
Yellow
Furthures
Antibacterial
Lead Time
25 Days
Furthure1
OEM
Furthure2
Cavity Wounds;Exuding Wounds;Burn Wounds
Furthure3
Antibacterial Action
Transport Package
1 PC/Pouch
Trademark
OEM brand
Origin
Cn
HS Code
3006700000
Production Capacity
5, 000, 000 PCS/Year

Product Description


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 faecalisATCC 29219Dressing 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 coliATCC 8739
Klebsiella pneumoniaeATCC 4352
Pseudomonas aeruginosaATCC 9027
Staphylococcus aureusATCC 6538
Streptococcus pyogenesATCC 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 1Replicate 2Replicate 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 1Replicate 2Replicate 3
Staphylococcus aureus>4.0>4.0>4.0
Streptococcus pyogenes>4.1>4.1>4.1
Enterococcus faecalis2.11.62.6
Escherichia coli>4.3>4.3>4.3
Klebsiella pneumoniae>4.2>4.2>4.2
Pseudomonas aeruginosa>4.0>4.0>4.0

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