21 CFR 880.5240 — Strip, Adhesive, Closure, Skin
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5240
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | 1 | 35 | 3rd Party |
| KGX | Tape And Bandage, Adhesive | 1 | 187 | |
| MZR | Topical Approximation System | 1 | 0 | |
| PYO | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | 1 | 1 |
