Product Classification

• Device: drape, surgical
• Regulation Description: Surgical drape and drape accessories.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: KKX
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 878.4370
• 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 Standards

• 6-296 AAMI ANSI PB70:2012
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• 6-306 ASTM F1671/F1671M-13
  Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
• 6-402 ASTM F1670/F1670M-17
  Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• 6-487 AAMI ANSI PB70:2022
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• 6-491 ASTM F1670/F1670M-17a
  Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• 6-496 ASTM F739-20
  Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact

Guidance Document

• Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes

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