(629 days)
Prescription use:
Under the supervision of a healthcare professional:
LUOFUCON® Silver Gelling Fiber Surgical Dressing may be used for the management of surgical wounds as an effective barrier to microbial penetration of the dressing.
OTC use:
LUOFUCON® Antibacterial Gelling Fiber Cover Dressing may be used for: Minor abrasions: Minor lacerations; Minor cuts; Minor scalds and burns.
LUOFUCON® Silver Gelling Fiber Surgical Dressing is a sterile post-operative dressing, comprising of polyurethane film, super absorbent fiber non-woven pad, silver gelling fiber non-woven pad (wound contact) containing 1.1% (w/w) ionic silver, and silicone qel. A windowed self-adhesive silicone skin contact layer plays a role of minimizing the trauma on removal, and alleviating the leakage of exudate.
The compliance and the softness of the dressing are improved effectively by using the notched non-woven pad, thus it is easier to apply on the wounds/parts which are difficult to paste. The highly absorbent dressing has a strong exudate management. When absorbing the wound fluid, the dressing will form a soft gel to support a moist wound healing environment. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.
Based on in vitro performance data, the LUOFUCON® Silver Gelling Fiber Surgical Dressing is waterproofness and breathable. The polyurethane film of dressing provides a microbial barrier to prevent the microbial penetrating through it, and the silver component prevents the growth of the bacteria within the dressing up to 7 days.
I am sorry, but the provided text describes a medical device (surgical dressing) that is not an AI/ML powered device. Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study details for an AI-powered device. The text does not contain information on AI/ML models, test sets, ground truth establishment, or human-in-the-loop performance.
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