(a) Identification. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(b) Classification. Class I (general controls). [45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001]