Product Classification

• Device: mask, surgical
• Regulation Description: Surgical apparel.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: FXX
• 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

• 6-406 ASTM F1862/F1862M-17
  Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• 6-492 ASTM F2100-23
  Standard Specification for Performance of Materials Used in Medical Face Masks
• 6-493 ASTM F2101-23
  Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• 6-504 ASTM F1862/F1862M-24
  Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

Guidance Document

• Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc