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Title 21 Part 880 → Subpart F → §880.5240

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5240

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5240

e-CFR data is current as of July 12, 2019

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5240


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices


§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.

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