21 CFR 880.6250 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — General Hospital And Personal Use Devices (§ 880.1 To § 880.6992) — General Hospital And Personal Use Miscellaneous Devices (§ 880.6025 To § 880.6992) — Patient examination glove.

4 Aug 2016

(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).

21 CFR 880.6250
[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001]