Profile: Winner Industries (Shenzhen) Co., Ltd. is a manufacturer of a wide range of disposable wound care and surgical medical products. Our product categories are surgical dressings, dressing packs, wound care dressings, protective products, medical instruments, dental products and hygiene products. We offer medical instruments such as disposable syringes, infusion sets, blood bags, urine bags, blades, sutures, forceps and vaginal dilators. Our vaginal dilator is smooth with no burr, and offers fine elasticity at the clamping point. Our disposable syringes are made of medical macromolecule material. They do not cause hemolysis and are non-toxic and pyrogen-free.

The company was founded in 1991 and is ISO 9001:2000, ISO 13485:2003, CE certified.

FDA Registration Number: 9616433
US Agent: David Lennarz / Register Corp
Phone: +1-(757)-224-0177  Fax: +1-(757)-224-0179  E-Mail:

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• Operating Room Shoes (FDA Code: FXW / 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.

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

• Padded Arm Sling

• Patient Examination Gowns & Capes

• 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.

• Pediatric Arm Sling

• Protective Surgical Cap

• Rubber Elastic Bandages

• Scalpel Blade (FDA Code: GES / 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.

• Self Adhesive Elastic Bandage

• Sterile Leg Urine Collection Bag for External Use (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:

• Sterile Specimen Trap (FDA Code: BYZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• 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.

• Strap Arm Sling

• Surgical Caps

• Surgical Caps (FDA Code: FYF / 878.4040)

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

• Surgical Mask for Nurses

• Surgical Masks (FDA Code: FXX / 878.4040)

• Surgical Suite

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Thoracotomy Arm Sling

• Tie-On Surgical Masks

• Tongue Depressors (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.

• Tubular Elastic Bandage Retainer

• Tubular Elastic Bandages & Nets

• Ultra-Soft Surgical Mask for Sensitive Skin Indicator Organism Testing

• Universal Arm Sling

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

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

• 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.