21 C.F.R. § 878.4380

Drape adhesive.

Last amended: 2016Year: 2026Length: 72 wordsSubsections: 2Official source

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.
21 C.F.R. § 878.4380: Drape adhesive. | Justis AI