(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.
Code of Federal Regulations
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]