Product Classification

• Device: drape, urological, disposable
• Regulation Description: Surgical drape and drape accessories.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: EYY
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(K) Exempt
• Regulation Number: 878.4370
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-296 AAMI ANSI PB70:2012
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• 6-363 ISO 11810 Second edition 2015-12-15
  Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
• 6-487 AAMI ANSI PB70:2022
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Third Party Review

Not Third Party Eligible