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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 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 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.

For over-the-counter use, Exufiber Ag+ may be used for: - · Abrasions - · Lacerations - Minor cuts - · Minor scalds and burns Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds: - · Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers - · Pressure ulcers (partial and full thickness) - Partial thickness burns - · Donor sites and other wounds that are prone to bleeding, such as debrided wounds - Traumatic wounds - Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions - · Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection. Indicated wear time: up to seven (7) days.

Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing that is intended to be used on medium to high exuding wound fluid, creating a soft gel and maintaining a moist wound healing environment. The dressing consists of a polyvinyl alcohol (PVA) pad or ribbon, coated on both sides with silver sulfate to act as a preservative in the dressing to inhibit or reduce microbial growth.

Mepiseal is intended to be used on periwound skin in conjunction with a wound dressing to prevent leakage and premature loosening of the dressing. It is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. When used under NPWT dressings, Mepiseal serves as a sealant to help create and maintain a seal, which enables delivery of effective negative pressure wound therapy. When used under NPWT dressings to aid in seal formation, Mepiseal is compatible with the Avance Dressing Kits that include Avance Film with Safetac Technology and Avance Transparent Film.

The subject device is a soft silicone sealant intended to be used on periwound skin in conjunction with a wound dressing and is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. Mepiseal serves the same function as the soft silicone layer of any wound dressing, to maintain the seal of the dressing around the wound. It is considered an accessory to the wound dressing and can be used under conventional wound dressings and under Negative Pressure Wound Therapy (NPWT) dressings.

Avance Y-connector S is intended for use in the Avance Negative Pressure Wound Therapy (NPWT) system, to connect and allow therapy of multiple wounds simultaneously by using one pump. 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 submission is the Avance® Y-Connector S, which is an accessory to the Avance® Negative Pressure Wound Therapy (NPWT) System. It allows connection of multiple dressing kits to one pump in order to accommodate large or multiple wounds. We have classified this device as Class II as it is directly indicated for use with an NPWT Pump which falls under that classification, and the Avance® Y-Connector S forms an integral part of the overall system when multiple wound sites require therapy. The Avance® Y-connector S is a polyurethane/polypropylene based single lumen Yconnector. It is designed to function with existing Avance® NPWT pumps and dressing kits by connecting the Avance® Canister Tubing to two single lumen transfer pads which are applied to the Avance® Foam dressings. Use of the Avance® Y-Connector S allows therapy and transportation of exudate from more than one wound simultaneously using one pump. A maximum of two Avance® Y-Connector S devices may be used to connect three wounds to one pump.

The Biogel® PI Micro Surgical Glove is a disposable device made of Poly-Isoprene material that is intended to be worn on the hands, usually in surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The subiect device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic Poly-Isoprene material (not made from natural rubber latex). The gloves are manufactured using hand-specific molds (right and left hand). Each glove contains a beaded cuff to help reduce cuff roll-down during use.