(307 days)
SoftSeal-C is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.
SoftSeal-C pad is a sterile topical pad, packed in a foil pouch, and sterilized with gamma irradiation to a 10-6 SAL. The SoftSeal-C pad is a non-woven pad composed of chitosan fibers attached to a thin polypropylene backing material. The SoftSeal-C is formed as a 1" by 1" square pad 0.4" thick. The soft, fleece-like pad consists of fine (5 to 20 micrometer) chitosan fibers spun from high molecular weight chitosan. The chitosan fleece is attached to a thin polypropylene backing, which provides dimensional support for fabricating and handling the soft fibers.
The provided document is a 510(k) premarket notification for the SoftSeal-C device, specifically outlining its substantial equivalence to predicate devices for minor topical bleeding wounds. It does not contain information about the acceptance criteria or results from a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text. The document primarily focuses on regulatory approval based on substantial equivalence rather than presenting detailed study results for acceptance criteria.
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