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The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air. The chemical reaction results from the oxidation of iron.

The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material. Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts. Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.

Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam which together form a system for wound management via the application of negative pressure wound therapy. - . Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications - . Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate - . Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips - . Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds Avance Solo NPWT System maintains negative pressure nominally at -125 mmHg to the wound and enables exudate management by absorption and evaporation in Avance Solo Border Dressing. Excess exudate is collected in Avance Solo Canister 50 ml. Avance Solo NPWT System is intended for adults.

The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.

The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.

The Biogel® PI Micro Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The subject device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic polyisoprene material (not made from natural rubber latex).

The Avance® NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject device of this submission, the Avance Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad™ and Mepitel® is an offering of components developed for negative pressure wound therapy. These dressing kits which are intended for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac ViewPad™ and Mepitel® is a combination of different components developed and arranged to meet the needs of the clinician for specific size and types of wounds.

Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Biogel® PI UltraTouch™ G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject devices are disposable powder-free surgical gloves that are supplied sterile and are not made from natural rubber latex. They have been tested for use with chemotherapy agents. The Biogel® PI UltraTouch™ G surgical gloves are made from synthetic polyisoprene material and the Biogel® SkinSense® surgical gloves are made from synthetic polychloroprene material. The gloves have been previously 510(k) cleared through K050184 and K053102 respectively.

The BARRIER® EasyWarm® Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The BARRIER® EasyWarm® Active Self-Warming Blanket is a disposable blanket 152 x 92 cm in size. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its' packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air.

The Biogel® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The proposed device, the Biogel® PI OrthoPro® Brown Surgical Glove is manufactured of non-latex (polyisoprene) colored with brown pigmentation. The Biogel® Pl OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years. The differences in the proposed glove and the predicate are as follows: - Addition of a Brown Colorant . - Thicker Glove . - New Former . The glove former design used in the manufacture of this glove allows the Biogel® PI OrthoPro® Brown Surgical Glove to provide the user with this additional feature: - Slightly Curved Former with Independent/Displaced thumb ●

The Skinsense Polyisoprene Underglove is a disposable device made of non-natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Skinsense Polyisoprene Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

The Biogel Eclipse Indicator Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel Eclipse Indicator Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.