Section 880.6250 - Non-powdered patient examination glove(a)Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9 .45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952 , Sept. 10, 2001; 81 FR 91730 , Dec. 19, 2016; 84 FR 71815 , Dec. 30, 2019 81 FR 91730, 1/18/2017; 84 FR 71815, 12/30/2019