concerning records, and § 820.198, with respect to complaint files.

§ 880.6250 Patient examination glove. (a) Identification. 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.

(b) Classification. Class I (general controls).

[45 FR 69682-69737, Oct. 21, 1980, as amended at 53 FR 1604, Jan. 13, 1989]

§ 880.6265 Examination gown.

(a) Identification. 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.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

§ 880.6280 Medical insole.

(a) Identification. 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.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989]

§ 880.6320 AC-powered medical examination light.

(a) Identification. An AC-powered medical examination light is an ACpowered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

(b) Classification. Class I. The device is exempt from the premarket notifica

(a) Identification. A battery-powered medical examination light is a batterypowered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

§ 880.6375 Patient lubricant.

(a) Identification. 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.

(b) Classification. Class I (general controls).

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

§ 880.6500 Medical ultraviolet air purifier.

(a) Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.

(b) Classification. Class II (performance standards).

§ 880.6730 Body waste receptacle.

(a) Identification. A body waste receptacle is a device intended for medical purposes tht is not attached to the body and that is used to collect the body wastes of a bed patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a) Identification. 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).

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §880.9.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

§ 880.6760 Protective restraint.

(a) Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others. (b) Classification. Class I (general controls).

[61 FR 8439, Mar. 4, 1996]

§ 880.6775 Powered patient transfer device.

(a) Identification. A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

§ 880.6785 Manual patient transfer device.

(a) Identification. A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807. The divice also is exempt from the good manufacturing

practice regulation in part 820, with the exception of §820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

§ 880.6800 Washers for body waste receptacles.

(a) Identification. A washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan. The device consists of a wall-mounted plumbing fixture with a door through which a body waste receptacle is inserted. When the door is closed the body waste receptacle is cleaned by hot water, steam, or germicide.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820 with the exception of § 820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

§ 880.6820 Medical disposable scissors.

(a) Identification. Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807.

§ 880.6850 Sterilization wrap.

(a) Identification. 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.

(b) Classification. Class II (performance standards).

§ 880.6860 Ethylene oxide gas sterilizer.

(a) Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care pro

vider that uses ethylene oxide (ETO) to sterilize medical products.

(b) Classification. Class II (performance standards).

§ 880.6870 Dry-heat sterilizer.

(a) Identification. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.

(b) Classification. Class II (performance standards).

§ 880.6880 Steam sterilizer.

(a) Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

(b) Classification. Class II (performance standards).

§ 880.6885 Liquid chemical sterilants/ high level disinfectants.

(a) Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

(b) Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

[65 FR 36325, June 8, 2000]

§ 880.6890 General purpose disinfectants.

(a) Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.

(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 the limitations in § 880.9.

[65 FR 36326, June 8, 2000]

§ 880.6900 Hand-carried stretcher.

(a) Identification. A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994]

§ 880.6910 Wheeled stretcher.

(a) Identification. A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

§ 880.6920 Syringe needle introducer.

(a) Identification. A syringe needle introducer is a device that uses a springloaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

(b) Classification. Class II (performance standards).

§ 880.6960 Irrigating syringe.

(a) Identification. 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 ir

rigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

§ 880.6970 Liquid crystal vein locator.

(a) Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989]

§ 880.6980 Vein stabilizer.

(a) Identification. A vein stabilizer is a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed on the skin so that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted into the vein.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it is also exempt from the good manufacturing practice regulation in part 820, with the exception of § 820.180, general requirements concerning records, and § 820.198, with respect to complaint files.

§ 880.6990 Infusion stand.

(a) Identification. The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in