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The HemCon Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.

The HemCon Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

Hem Con ChitoFlex PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

The HemCon Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

The HemCon Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Strip First Aid PRO also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.

The HemCon Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

Device Description

The HemCon® Bandage family of products are lyophilized (freeze dried) chitosan based dressings designed to optimize the muco adhesive surface density and structural integrity of chitosan at the site of injury. The bandages are soft, pliable, off-white, non-woven, lamellar dressings composed of a non-mammalian biocompatible, hydrophilic cellulose polymer, poly-N-acetylglucosamine (NAG), isolated from arctic shrimp "Pandalus Borealis' chitosan.

When applied directly to a wound the dressing controls bleeding. The chitosan dressings offer an antibacterial barrier against a wide range of gram positive and gram negative organisms including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.

The HemCon Bandage Family of products may be manufactured to any size and are currently available in sizes: 1.5" x 1.5", 1" x 4", 2" x 2", 2"x 4", 4"x 4",3" x 9″ and 3" x 28".

The HemCon Bandage family products are safe, durable, highly effective, and do not contain human proteins or clotting factors.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the HemCon® Bandage family of products, based on the provided text:

Acceptance Criteria and Reported Device Performance

Although specific numerical acceptance criteria (e.g., "hemostasis achieved in X% of cases") are not explicitly stated as strict pass/fail thresholds in the provided text, the studies aimed to demonstrate the device's ability to achieve hemostasis in specific scenarios and provide an antibacterial barrier. The reported performance below reflects the positive outcomes that led to the substantial equivalence determination.

Acceptance Criteria / Performance Goal	Reported Device Performance
Biocompatibility	The devices are considered dressings for prolonged contact (24 hours to 30 days) with breached or compromised tissue surfaces and are recommended to be removed within 48 hours. Demonstrated compliance with ISO-10993 and USP :2007 through tests for Cytotoxicity, Sensitization, Irritation, and Systemic Toxicity.
Antibacterial Barrier Efficacy	"Log reduction of 4.0 or greater achieved on all of the organisms tested supporting the antibacterial barrier claim." (Organisms tested included: Acinetobacter baumannii, Enterococcus faecalis (VRE), Moraxella catarrhalis, Shigella species, Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes).
Hemostasis in Anticoagulated Populations (Animal Study)	"Hemostasis time in the HemCon group was significantly less than the control."
Hemostasis in Complicated Epistaxis (Clinical Study 1)	"19 out of 20 subjects achieving immediate hemostasis" in patients on anticoagulant therapy, with no rebleeding or adverse events at 48 hours post-removal.
Time to Hemostasis in Catheterization Patients on Anticoagulation (Clinical Study 2)	"Time to hemostasis with HemCon Bandage was lower (p

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