Silver Alginate Dressing
510(k) Number:
K202982
Indications for Use:
Silver Alginate Dressing (Prescription use) 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.
Antibacterial Alginate Wound Dressing (OTC use) is first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
Description:
It is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent. The dressing absorbs wound exudate and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within 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 bacteria 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, Bacillus subtilis, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus (VRE), Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae for up to seven days.
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