§ 878.4470. Surgeon's gloving cream.
75 words·~1 min read·
/us/cfr/t21/s§ 878.4470·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]