21 CFR § 878.4380 General and Plastic Surgery Devices

§ 878.4380 Drape adhesive.

Current through Sep 8, 2026 · Read all of Part 878

(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]

← § 878.4371 Irrigating wound retractor device.§ 878.4400 Electrosurgical cutting and coagulation device and accessories. →