(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]