---
kind: "section"
citation: "21 C.F.R. § 886.4750"
title: "21"
number: "886.4750"
heading: "Ophthalmic eye shield."
url: "https://uscodex.org/cfr/21/886.4750"
---

# §886.4750. Ophthalmic eye shield.

- (a) **Identification.** An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
- (b) **Classification.** Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 886.9](/cfr/21/886.9.md). When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, 2000; 90 FR 55992, Dec. 4, 2025]

### Authority

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

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, 2000; 90 FR 55992, Dec. 4, 2025]