(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).
Code of Federal Regulations
[45 FR 69682-69737, Oct. 21, 1980, as amended at 53 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001]