Product Classification

• Device: respirator, surgical
• Regulation Description: Surgical apparel.
• Definition: A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1).
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: MSH
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(K) Exempt
• Regulation Number: 878.4040
• 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

• 6-406 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)
• 6-427 ASTM F2101-19
  Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• 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

Not Third Party Eligible