FDA Approved Calcium Silver Antibacterial Alginate Wound Dressing High Absorption

Min.Order: 10,000
Product origin: Huizhou, Guangdong, China
Infringement complaint: complaintComplaint
US$ 0.5 ~ 0.6

Description
Product Description:

First FDA approvrd silver antibacterial dressing in China.

LUOFUCON®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.


 
Silver Release:
Figure1 shows that LUOFUCON® 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.
 
LUOFUCON® 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.
 
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



 

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

  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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