Product Classification

• Device: sterilizer, chemical
• Regulation Description: Ethylene oxide gas sterilizer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: MLR
• 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: 880.6860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 14-588 AAMI TIR17:2017/(R)2020
  Compatibility of materials subjected to sterilization
• 19-42 IEC 61326-1 Edition 3.0 2020-10
  Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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