21 C.F.R. § 878.4380
Drape adhesive.
Cite as 21 C.F.R. § 878.4380 (2026)
(a)
Identification.
A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
(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 § 878.9.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]
- Cross-references to the CFR
- 878.9.