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21 CFR 880.6850

§ 880.6850 Sterilization wrap.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 880.6850, § 880.6850 Sterilization wrap, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90603
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(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.