(a) Identification.
         A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
     
    
        
        (b) Classification.
         Class I (general controls).
     
    
        
            Code of Federal Regulations
        
        [45 FR 69682-69737, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001]