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Code · CFR · Title 21 — Food and Drugs · Part 880 — General Hospital and Personal Use Devices · § 880.5240

§ 880.5240. Medical adhesive tape and adhesive bandage.

129 words·~1 min read·/us/cfr/t21/s§ 880.5240·

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(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]
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§ 880.5240
Medical adhesive tape and adhesive bandage.
Fed. Reg.×1
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