lubricating or dusting powder used in the glove is excluded. (b) Classification. Class I. § 878.4470 Surgeon's gloving cream. (a) Identification. Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994] § 878.4480 Absorbable powder for lubricating a surgeon's glove. (a) Identification. Absorbable powder for lubricating a surgeon's glove is a powder made from corn starch that meets the specifications for absorbable powder in the United States Pharmacopeia (U.S.P.) and that is intended to be used to lubricate the surgeon's hand before putting on a surgeon's glove. The device is absorbable through biological degradation. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See §878.3. § 878.4490 Absorbable agent and dressing. hemostatic (a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See §878.3. § 878.4493 Absorbable poly(glycolide/Llactide) surgical suture. (a) Identification. An absorbable poly(glycolide/L-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent Llactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures; it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached. (b) Classification. Class II. [56 FR 47151, Sept. 18, 1991] § 878.4495 Stainless steel suture. (a) Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure. (b) Classification. Class II (special controls). [65 FR 19836. Apr. 13, 2000] $878.4520 Polytetrafluoroethylene injectable. (a) Identification. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3. § 878.4580 Surgical lamp. (a) Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. (b) Classification. Class II. § 878.4630 Ultraviolet lamp for dermatologic disorders. (a) Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. (b) Classification. Class II. $878.4635 Ultraviolet lamp for tanning. (a) Identification. An ultraviolet lamp for tanning is a device that is a lamp (including a fixture) intended to provide ultraviolet radiation to tan the skin. See §1040.20 of this chapter. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994] § 878.4660 Skin marker. (a) Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994] § 878.4680 Nonpowered, single patient, portable suction apparatus. (a) Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4700 Surgical microscope and accessories. (a) Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994] § 878.4730 Surgical skin degreaser or adhesive tape solvent. as (a) Identification. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such 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. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994] § 878.4750 Implantable staple. (a) Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable. (b) Classification. Class II. § 878.4760 Removable skin staple. (a) Identification. A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] $ 878.4780 Powered suction pump. (a) Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter. (b) Classification. Class II. § 878.4800 Manual surgical instrument for general use. (a) Identification. 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 in separate regulations parts 868 through 892. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994] § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. (a) Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. (2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. (b) Classification. (1) Class II. (2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996] § 878.4820 Surgical instrument motors and accessories/attachments. (a) Identification. 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. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000] § 878.4830 Absorbable surgical gut suture. (a) Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation. (b) Classification. Class II. [54 FR 50738, Dec. 11, 1989] § 878.4930 Suture retention device. (a) Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994] § 878.4950 Manual operating table and accessories and manual operating chair and accessories. (a) Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994] § 878.4960 Operating tables and accessories and operating chairs and accessories. (a) Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or airpowered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, Jan. 14, 2000] § 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture. (a) Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached. a (a) Identification. Nonabsorbable polypropylene surgical suture is monofilament, nonabsorbable, sterile, flexible thread prepared from longchain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached. (b) Classification. Class II. [56 FR 24685, May 31, 1991] § 878.5020 Nonabsorbable surgical suture. polyamide (a) Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached. (b) Classification. Class II. [56 FR 24685, May 31, 1991] § 878.5030 Natural nonabsorbable silk surgical suture. (a) Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s). (b) Classification. Class II (special controls). FDA recognized consensus standards and device-specific labeling: (1) United States Pharmacopoeia (USP) 21: (i) Monograph for Nonabsorbable Surgical Sutures; (ii) Sutures-Diameter <861>; (iv) Tensile Strength <881>. (2) Labeling: (i) Contraindication: "This device is contraindicated for use in ophthalmic and neural tissues and for use in microsurgery." (ii) "For Single Use Only." (iii) If the marketed suture has a different diameter than the diameter specified in USP 21-Suture Diameter <861>, then a tabular comparison of its diameter and USP sizes should be included in the labeling. [65 FR 20735, Apr. 18, 2000] §878.5040 Suction lipoplasty system. (a) Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters. | tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap. (b) Classification. Class II (special controls). Consensus standards and labeling restrictions. [63 FR 7705, Feb. 17, 1998] Subpart F-Therapeutic Devices § 878.5070 Air-handling apparatus for a surgical operating room. (a) Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed. nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient. (b) Classification. Class II. § 878.5350 Needle-type epilator. (a) Identification. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996] §878.5360 Tweezer-type epilator. (a) Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove |