Search Results

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 Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials 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 Biogel® surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene.

The Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, 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® PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim 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.

Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.

The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, 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® PI UltraTouch S 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.

Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.

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 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 exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this premarket notification is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large. The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847: Avance ViewPad, Avance Foam (green), Avance Transparent Film.

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 exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components: - Antimicrobial gauze dressing - Avance Transparent Film or Avance Film with Safetac technology - Avance ViewPad

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 exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness bums, flaps and grafts.

The subject Avance Tubing serves as the connecting link between the Avance NPWT pump and the Avance dressings, thereby delivering negative pressure wound therapy from the pump to the wound bed and facilitating the transport of fluid and exudate from the wound site to the canister. It consists of a 1.5 m length of tubing with connectors on each end to facilitate connection to other components of the Avance NPWT System. The subject Avance Y-Connector allows connection of multiple Avance dressings to one Avance pump in order to accommodate large or multiple wounds. It consists of y-tubing with connectors on all ends to facilitate connection to other components of the Avance NPWT System. A maximum of one Avance Y-Connector may be used to connect up to two large dressing kits to a single pump. The subject Avance ViewPad used in conjunction with the Avance dressings; it is placed on top of the wound cover (film), connected to the wound filler via a hole cut in the wound cover, and then connected to the Avance NPWT pump tubing for delivery of NPWT and transport of fluids and exudate away from the wound. The subject Avance ViewPad is similar to the existing ViewPad component of the Avance Foam Dressing Kits (K141847), with the exception of a green colorant that has been added to the connector and a modification to the design of the slide clamp.