§ 880.6250. Non-powdered patient examination glove.
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/us/cfr/t21/s§ 880.6250·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 880.6250
Non-powdered patient examination glove.
Fed. Reg.×15
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