Product Classification

• Device: sterilizer, ethylene-oxide gas
• Regulation Description: Ethylene oxide gas sterilizer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FLF
• Submission Type: 510(k)
• Regulation Number: 880.6860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• AAMI/ANSI ST24:1999/(R) 2009 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.