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510(k) Review for Surgical Mask 

Office of Health Technology 4: Surgical and Infection Control Devices

Office of Product Evaluation and Quality (OPEQ)

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration (FDA)
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Surgical Mask: 

510(k) Submission General Contents

• 21 CFR §878.4040(b), Product Code FXX

– A surgical mask covers the user’s nose and mouth and provides a physical 

barrier to fluids and particulate materials. The surgical masks referenced 

in the guidance document include masks that are labeled as a surgical, 

laser, isolation, dental or medical procedure masks.

• Submission Contents

– Device Description

– Subject & Predicate Device Comparison

– Labeling
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Safety Assessment

• Biocompatibility

– Surface Contacting, Prolonged Duration

– Endpoints to Assess

• Cytotoxicity (ISO 10993-5)

• Irritation/Intra-cutaneous reactivity (ISO 10993-10)

• Sensitization (ISO 10993-10)
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Performance Testing

• Fluid Resistance

• Filtration Efficiency

– Bacterial Filtration Efficiency

– Particulate Filtration Efficiency

• Differential Pressure (Delta-P) Test

• Flammability Testing

www.fda.gov
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Resources • Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff

https://www.fda.gov/media/71660/download

• Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: 

Evaluation and testing within a risk management process”: Guidance for Industry and Food and Drug 

Administration Staff 

https://www.fda.gov/media/85865/download

• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for 

Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff 

https://www.fda.gov/media/74445/download

• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]:

Guidance for Industry and Food and Drug Administration Staff 

https://www.fda.gov/media/82395/download

• 510(k) Submission Process Web Page

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
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Resources • ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=39911

• ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal 

Projection of Fixed Volume at a Known Velocity)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=36979

• 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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=39935

• ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=38569

• ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=36819

• ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=36826

• ISO 2859-1 Sampling procedures for inspection attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) 

for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1(2011)]

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32318

• ANSI ASQ Z1.4-2003 Sampling Procedures and Tables for Inspection by Attributes

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32711
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Slide Presentation, Transcript and Webinar Recording 

will be available at:

www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics and Sub-heading

Personal Protective Equipment (PPE)

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