21 C.F.R. § 878.4470

Current through May 31, 2024
Section 878.4470 - Surgeon's gloving cream
(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 .

21 C.F.R. §878.4470

53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001