---
kind: "section"
citation: "21 C.F.R. § 880.6250"
title: "21"
number: "880.6250"
heading: "Non-powdered patient examination glove."
url: "https://uscodex.org/cfr/21/880.6250"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 880.9](/cfr/21/880.9.md).

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[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]