Product Classification

• Device: gown, isolation, surgical
• Regulation Description: Surgical apparel.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: FYC
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 878.4040
• 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

• 6-402 ASTM F1670/F1670M-17
  Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• 6-448 ASTM F2407-20
  Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• 6-474 ASTM F3352-19
  Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• 6-487 AAMI ANSI PB70:2022
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• 6-488 ASTM F1671/F1671M-22
  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
• 6-494 ASTM F3352/F3352M-23a
  Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• 6-496 ASTM F739-20
  Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
• 14-286 ANSI AAMI ST65:2008/(R)2018
  Processing of reusable surgical textiles for use in health care facilities

Guidance Document

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

Third Party Review

Not Third Party Eligible