Profile: Dynarex Corporation supplies antiseptic products, incontinent care, gloves, patient care, wound care, nursing and urologicals. Our PVP iodine ointment is an antiseptic, antimicrobial ointment, which is effective against gram positive and gram negative bacteria & yeasts. Our powder free vinyl exam gloves are ideal for health care personnel with acute sensitivity to powdered gloves. We also offer a line of infection control, antiseptic, isolation gowns, face masks, and patient care products. Our molded face masks are manufactured of soft, cool, comfortable materials. It is fiberglass free, fluid resistant and has flared soft edges to fit all facial contours. It is latex free, has adjustable aluminum nose piece and dual head straps for tight facial seal.

The company has revenues of USD 25-50 Million, has ~30 employees and is CE certified.

FDA Registration Number: 3003467879
US Agent: Frederic Boli Emch / Denovo Jet (dba - Arex Denovo)
Phone: +1-(434)-227-0003  E-Mail:

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• Obstetrical Kits (FDA Code: OKV / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• 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.

• One-Piece Scalpel (FDA Code: GDX / 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.

• Operating Room Shoe Cover (FDA Code: FXP / 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.

• 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.

• Oral Airway Kit

• Oral Berman Airways

• Ostomy Drainage Bag (FDA Code: FON / 876.5900) An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

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

• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

• Oxygen Nasal Cannula (FDA Code: CAT / 868.5340) A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.

• Paper Face Masks

• Paper Surgical Tape

• Patient Examination Gowns and Capes (FDA Code: FME / 880.6265) An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

• Patient Lubricant (FDA Code: KMJ / 880.6375) A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

• Plaster Gauze

• Plastic Patient Utensils

• Plastic Pitcher With Lid

• Poly Patient Examination Glove (FDA Code: LZA / 880.6250) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

• Polyethylene Aprons

• Povidone Iodine Prep Pads

• Preps & Swabs

• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

• Protective Padding & Dressings

• Razors

• Rubber Elastic Bandages

• Safety Razors

• Scalpel Blade (FDA Code: GES / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Self Adhesive Elastic Bandage

• Self-Adherent Wraps/Bandages

• Sheer Plastic Spot Bandages

• Shoe Covers

• Skin Protectant Liquid Bandage (FDA Code: NEC / 880.5090) A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

• Specialized Obstetric-Gynecologic Manual Instrument (FDA Code: KNA / 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:

• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 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.

• Sterile Alcohol Prep Pads

• Sterile Gauze

• Sterile Specimen Container (FDA Code: FMH / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Sterile Specimen Mailer and Storage Container (FDA Code: KDT / 864.3250)

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Straight Razors

• Surgeon's Gloves (FDA Code: KGO / 878.4460) A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

• Surgical Caps

• Surgical Caps (FDA Code: FYF / 878.4040)

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Surgical Isolation Gown (FDA Code: FYC / 878.4040)

• Surgical Masks (FDA Code: FXX / 878.4040)