21 CFR § 880.6850 - Sterilization wrap.

---
identifier: "/us/cfr/t21/s880.6850"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.6850 - Sterilization wrap."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.6850"
section_name: "Sterilization wrap."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 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).