21 CFR § 878.4470 - Surgeon's gloving cream.
§ 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.