21 C.F.R. § 878.4470

Surgeon's gloving cream.

Last amended: 2016Year: 2026Length: 75 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 878.4470 (2026)

(a) Identification. Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove. (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 38803, July 25, 2001]
Cross-references to the CFR
878.9.
21 C.F.R. § 878.4470: Surgeon's gloving cream. | Justis AI