---
kind: "section"
citation: "21 C.F.R. § 880.6850"
title: "21"
number: "880.6850"
heading: "Sterilization wrap."
url: "https://uscodex.org/cfr/21/880.6850"
---

# §880.6850. Sterilization wrap.

- (a) **Identification.** A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
- (b) **Classification.** Class II (performance standards).

## Notes

### 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.