Profile: Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing products, oxygen regulator and diabetic care products. We provide gloves in small, large and extra large sizes for medical use. Our diabetic care products include glucose monitor kits and glucose test strips. We also provide surgical instruments such as bone plasters, diagnostics, ear instruments, forceps, needles & probes, scissors, sponge and needle holders.

FDA Registration Number: 1062671

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• Urine Collection Leg Bags (FDA Code: FAQ / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Urine Leg Bags (FDA Code: FAQ / 876.5250)

• Ventilator Tubing and Support Set (FDA Code: BZO / 868.5975) Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

• Wheelchair Accessories (FDA Code: KNO / 890.3910) A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

• Wheelchair Belt (FDA Code: IQB / 890.3920) A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.

• Wheeled (Mobile) Stretcher (FDA Code: FPO / 880.6910) A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.

• X-Ray Detectable Gauze (FDA Code: GDY / 878.4450) Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.

• Y Piece Breathing Circuit (FDA Code: CAI / 868.5240) An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.