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§ 880.6100 Ethylene oxide gas aerator cabinet.

21 CFR 880.6100

Citation21 CFR 880.6100
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 880.6100 Ethylene oxide gas aerator cabinet.

(a) Identification. An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.

(b) Classification. Class II (performance standards).