---
kind: "section"
citation: "21 C.F.R. § 878.4370"
title: "21"
number: "878.4370"
heading: "Surgical drape and drape accessories."
url: "https://uscodex.org/cfr/21/878.4370"
---

# §878.4370. Surgical drape and drape accessories.

- (a) **Identification.** A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
- (b) **Classification.** Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, 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 [§ 878.9](/cfr/21/878.9.md).

## Notes

### Amendments

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]