LUOFUCON® Extra Silver Alginate Dressing Receives FDA 510(k)
Recently, FORYOU MEDICAL received a good news from the FDA--our LUOFUCON® Extra Silver Alginate Dressing has passed the certification and receives FDA 510(k), which the number is K172554.
LUOFUCON® Extra Silver Alginate Dressing is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent, which absorbs wound exudate and release silver ions in the presence of wound fluid in the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The alginate material contains silver which inhibits bacterial growth within the dressing.Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant Enterococcus (VRE). And the silver protects the dressing from a broad spectrum of bacteria up to seven days.
All dressings are sterilized and sold after sterilization by radiation using conditions
validated following ISO 11137-2:2013.
LUOFUCON® Extra Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
If you are interested in this product, please contact our salesperson--