Profile: Dukal Corporation specializes in gauze products. We deliver a wide variety of wound care & specialty patient care products for all medical markets. We offer the medical community a solution in disposable patient care products. Each of our quality strip consists of thin, reinforced non-woven fibers that provide incision support to maintain closure. This adhesive backed product is translucent and breathable to promote good healing. Our Caliber™ non-woven island dressings provide combination of protection and comfort. This absorbent pad collects excess exudates and protects the wound from trauma to allow for quick healing. The soft non-woven adhesive border is gentle on the skin, ensures comfortability, breathability, and ease of movement. It is available in 6 sizes, is sterile & latex free.

The company was founded in 1991, has revenues of USD 25-50 Million, has ~40 employees and is ISO 9002 certified.

FDA Registration Number: 2435946

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• Gauze Trays

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• General Dressings

• General EMT

• General Medical Supplies

• General Orthopedic Supplies

• Hospital Scrubs

• Hydrophilic Wound Dressings (FDA Code: NAC / 878.4018) A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Import/Export Service

• Incontinence Garments

• Infant Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Internal Gauze/Sponge (FDA Code: EFQ)

• Junior Tongue Depressor (FDA Code: FMA / 880.6230)

• Laparotomy Sponges

• Latex Free Waterproof Adhesive Tape

• Lymphedema Compression Garments

• Mattress Cover (FDA Code: FMW / 880.6190) A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.

• Medical Absorbent Fiber (FDA Code: FRL / 880.5300) A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.

• Medical Adhesive Tape

• Medical Adhesive Tape Removers

• Medical Dressings, Gauze

• Medical Garments

• Medical Jacket and scrubs

• Medical Scrubs

• Medical Support Stocking (FDA Code: FQL / 880.5780) A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.

• Miscellaneous Deodorizers

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non-Adherent Dressing

• Non-Metal Vaginal Speculum (FDA Code: HIB / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Non-Pneumatic Tourniquet (FDA Code: GAX / 878.5900) A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Non-sterile Gauze Roll Bandages

• Non-Surgical Isolation Gown (FDA Code: OEA / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Non-Surgical Tongue Depressor (FDA Code: FMA / 880.6230)

• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Nonwoven Cotton Sponges

• Nursing Scrubs

• Occlusive Wound and Burn Dressing (FDA Code: MGP)

• Occlusive Wound Dressing (FDA Code: NAD / 878.4020) An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Operating Room Shoe Cover (FDA Code: FXP / 878.4040)

• Ophthalmic Eye Pad (FDA Code: HMP / 878.4440) An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.

• OSHA Compliant, Protective Disposable Garments

• Oval Eye Pads (FDA Code: HMP / 878.4440)

• Patient Examination Gowns & Capes

• Pediatric Garments

• Pediatric Urine Collector (FDA Code: KNX / 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:

• Percutaneous Tracheostomy Kits

• Plaster Gauze

• Post Operative Cotton Sponges

• Post-Surgery Compression Garments