Antibacterial AG Wound Dressing Alginate

Certification: CE, FDA, ISO13485
Type: Exudate Management
Feature1: Antibacterial Action
Feature2: Different Size Available
Feature3: 510k Cleared
Feature5: on Time Delivery
Customization:

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Rating: 5.0/5
Manufacturer/Factory, Group Corporation

Basic Info.

Model NO.
ASD0006
Feature4
Private Label
Feature6
User Friendly
Material
Silver Alginate
Ethylene Oxide Sterilization
Gamma
Quality Guarantee Period
Three Years
Group
All
Logo Printing
With Logo Printing
Transport Package
PE Film Packaging
Specification
10 pcs per package and customization
Trademark
FORUSORB
Origin
Huizhou, Guangdong, China
HS Code
3006700000
Production Capacity
50, 000, 000 PCS/Year

Product Description

Product Description:

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.
 
1. 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

 
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

 
2.3 Additional Study
Besides the six clinical-relevant bacteria above, we made an additional study for one drug-resistant bacteria(MRSA) and one fungus(Candida albicans).
 

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