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A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon's hand to prevent contamination between patient and surgeon.

The device in this 510(k) submission is the SensiCare -C Synthetic Polyisoprene Powder-free Surgical Glove (Classification number 79KGO). The SensiCare C Synthetic Polyisoprene Powder-free Surgical Glove is a sterile, synthetic rubber latex surgical glove. These gloves are intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The product is a powder-free, sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves.

Sniper Elite™ Hydrophilic Guidewires are designed for use in angiographic procedures to introduce/position catheters and interventional devices within the vasculature.

The Sniper Elite™ Hydrophilic Guidewire is constructed from a super elastic, Nitinol core wire. A plastic cladding is applied over the Nitinol core, with a hydrophilic coating covering the plastic cladding. The polymer cladding is impregnated with a radiopacive agent and a platinum/8% tungsten coil is located in the distal tip for enhanced contrast under fluoroscopy.

The Maxxim Medical angiographic catheters are designed to be used for delivering radiopaque contrast media into the coronary or peripheral vascular systems.

The Pathfinder II Angiographic catheter has a polyurethane body, reinforced with stainless steel braid, containing barium sulfate and a blue colorant. The braiding provides torque-ability. The barium sulfate causes the device to be radio-detectable under a fluoroscope to assist in placing the device in the patient's vasculature. The proximal end of the body is bonded to a polycarbonate hub. The distal end has a polyurethane stem fused to the braided body. All catheters have the distal tip formed either into a pigtail for infusing fluids or into a special "selective" shape that is formed to facilitate rapid placement of the device in the desired location in the circulatory system by the doctor. All selective curves have a soft, atraumatic polyurethane tip fused to the stem. The pigtail catheters have their stems either straight or formed into an angle to allow for user preferences. Pigtail angiographic catheters have a pattern of "side holes" near the distal tip to allow increased infusion flow rate. The catheter is introduced using the Seldinger Technique, Artery Cut-down (Sones method), or the Introducer Technique.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. The cuff of the glove has been lengthened and the thickness increased to promote use of the glove for procedures where such features are beneficial. It is made with a poly (vinyl Chloride) polymer and a polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed as medical examination gloves. All requirements for physical properties and dimensions have been met for this intended use.