Product Classification

• Device: cabinet, ethylene-oxide gas aerator
• Regulation Description: Ethylene oxide gas aerator cabinet.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FLI
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.6100
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 14-588 AAMI TIR17:2017/(R)2020
  Compatibility of materials subjected to sterilization

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc