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510(k) Data Aggregation
(162 days)
Enhanced silver gelling fiber dressing (OTC) may be used for the management of:
- Abrasions
- Lacerations;
- Minor cuts;
- Minor scalds and burns.
Extra enhanced silver gelling fiber dressing (Rx only) may be used for the management of:
- Partial thickness (superficial second degree) burns;
- Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
- Surgical wounds left to heal by secondary intention such as dehisced surgical incisions;
- Surgical wounds that heal by primary intent such as dermatological and surgical incisions(e.g., orthopedic and vascular);
- Traumatic wounds;
- Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
Enhanced silver gelling fiber dressing (OTC)/Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is a soft, conformable, sterile dressing composed of sodium carboxymethyl cellulose fibers, strengthening layer (polyester), 1.2% (w/w) ionic silver, and stitched with enhance fibers (polyester). This conformable dressing absorbs wound fluid and creates a soft gel, provides a moist wound healing environment, and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. Based on in-vitro testing, the silver in the dressing inhibits bacterial growth in the dressing for up to seven days.
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