21 C.F.R. § 880.5240

Current through September 30, 2024
Section 880.5240 - Medical adhesive tape and adhesive bandage
(a)Identification. 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.
(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 .

21 C.F.R. §880.5240

45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001