Product Classification

• Device: antimicrobial keyboard
• Regulation Description: Ultraviolet (UV) radiation chamber disinfection device.
• Definition: To reduce microbial populations
• Physical State: Device resides on a motorized drawer that is contained in an enclosure, the drawer slides outside of the enclosure for use then retracts into the light-tight enclusure for UV disinfection after use
• Technical Method: Self disinfecting computer keyboard and touchpad that utilized germicidal ultraviolet light in an enclosure
• Target Area: Hands
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: OSZ
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.6600
• 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

• 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

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