21 CFR 880.5240
§ 880.5240 Medical adhesive tape and adhesive bandage.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5240, § 880.5240 Medical adhesive tape and adhesive bandage, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90531
- Permanent ID
ys:prov:90531@1- SHA-256
115da9b94f7af7c25cd40101be3bc9220bf4d66dd17f0b98d699faf88abdb1fd
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.