The industrial gloves are made form qualified natural latex compounding with certain acid resistant materials by the process of ionic dipping. They are widely used for protecting the fields of chemical industry, printing, dyeing, and electroplating.
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|• (FDA Code: KGX / 880.5240)|
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
|• (FDA Code: KOX / 878.4730)|
A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
|• (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.
|• (FDA Code: KGT / 878.4380)|
A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
|• (FDA Code: DWO / 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.
|• (FDA Code: ITG / 890.3025)|
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
|• (FDA Code: LGF / 888.5940)|
A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.
|• (FDA Code: IPG / 890.3025)|
|• (FDA Code: GCB / 878.4200)|
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
|• (FDA Code: FQZ / 880.2900)|
A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.
|• (FDA Code: FLK / 880.2920)|
A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
|• (FDA Code: MHW / 880.5075)|
An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.
|• (FDA Code: BWP / 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.
|• (FDA Code: GAA / 878.4800)|
|• (FDA Code: IMD / 890.5710)|
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
|• (FDA Code: KME / 880.6060)|
Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.
|• (FDA Code: JOK / 880.6820)|
Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.
|• (FDA Code: GAB / 878.4800)|
|• (FDA Code: GAJ / 878.4800)|
|• (FDA Code: FXO / 878.4040)|
|• (FDA Code: FQM / 880.5075)|
|• (FDA Code: MRL / 880.2740)|
A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.
|• (FDA Code: KCP / 874.5220)|
An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
|• (FDA Code: KCP / 874.5220)|
|• (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.
|• (FDA Code: HDG / 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:
|• (FDA Code: HTD / 878.4800)|
|• (FDA Code: FHR / 878.4800)|
|• (FDA Code: GFA / 878.4820)|
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
|• (FDA Code: GEN / 878.4800)|
|• (FDA Code: GAF / 878.4800)|
|• (FDA Code: LRW / 878.4800)|
|• (FDA Code: HDH / 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:
|• (FDA Code: FPF / 880.6085)|
A hot/cold water bottle is a device intended for medical purposes that is in the form of a container intended to be filled with hot or cold water to apply heat or cold to an area of the body.
|• (FDA Code: NAE / 878.4022)|
A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel 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.
|• (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.
|• (FDA Code: KYR / 880.6050)|
An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient.
|• (FDA Code: EXH / 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.
|• (FDA Code: FMA / 880.6230)|
|• (FDA Code: KGY / 878.4100)|
An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.
|• (FDA Code: FMA / 880.6230)|
|• (FDA Code: LZB / 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.
|• (FDA Code: KPD / 880.2200)|
A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.
|• (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.
|• (FDA Code: KYS / 880.6280)|
A medical insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture.
|• (FDA Code: HDF / 884.4520)|
|• (FDA Code: KES / 864.3010)|
Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
|• (FDA Code: KEW / 864.3010)|