21 CFR § 878.4380 - Drape adhesive.
§ 878.4380 Drape adhesive.
(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.