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Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound,

The following Indications are for Prescription Use or under the direction of a health care professional:

Venous ulcers
Diabetic ulcers
Pressure ulcers
Arterial ulcers
Superficial burns
Abrasions and lacerations
Donor sites
Incisions

The following Indications are for Over-the-Counter Use:

Abrasions
Minor Burns
Minor Cuts
Minor Lacerations

Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of Absorbent fibers fabricated into a felt or rope configuration.

Dermaphylyx Absorbent Fiber Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a fiber mat which provides an environment conducive to moist wound healing. The fiber mat facilitates traums free removal from the wound.

The provided text is a 510(k) summary for a medical device (Dermaphylyx Absorbent Fiber Wound Dressing). It discusses the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory clearance based on substantial equivalence, rather than direct performance testing against predefined criteria.

The information regarding acceptance criteria and a study to prove meeting them would typically be found in a more detailed technical report or clinical study summary, which is not present in this 510(k) summary document.

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