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Title 21 Part 880 → Subpart G → §880.6100

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6100

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6100

e-CFR data is current as of September 18, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6100


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§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).