21 CFR § 880.6850 General Hospital and Personal Use Devices

§ 880.6850 Sterilization wrap.

Current through Sep 8, 2026 · Read all of Part 880

(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).

← § 880.6820 Medical disposable scissors.§ 880.6855 Rigid sterilization container with electronic monitoring. →