AG Calcium Alginate Dressing with FDA 510k

• Type: Exudate Management
• Material: Silver Alginate
• Ethylene Oxide Sterilization: Gamma
• Quality Guarantee Period: Three Years
• Group: All
• Logo Printing: With Logo Printing
• Model NO.: SAD0004
• Certification: CE, FDA, ISO13485
• Feature1: Antibacterial Action
• Feature2: Different Size Available
• Feature3: 510k Cleared
• Feature5: on Time Delivery
• Feature4: Private Label
• Feature6: User Friendly
• 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 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

 
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

 
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).