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Performance Testing and Labeling Requirements for Surgical and Medical Face Masks

This guidance applies to surgical masks and other masks (isolation, procedure, and dental masks) regulated under 21 CFR §878.4040(b) class II, with product codes FXX (Surgical Mask) and MSH (Surgical N95 NIOSH certified Respirator). These devices are used by healthcare personnel to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material.

  1. Conduct comprehensive risk analysis before submission
  2. Prepare device description with detailed comparison to predicate device
  3. Perform required performance testing:
    • Fluid resistance
    • Filtration efficiency (if not NIOSH certified)
    • Differential pressure (if not NIOSH certified)
    • Flammability
  4. Document biocompatibility evaluation
  5. Prepare labeling with all required elements
  6. For N95 Respirators, obtain NIOSH certification
  7. Prepare summary report with test results or acceptance criteria
  8. Submit complete 510(k) documentation following recommended format

Key Considerations

Non-clinical testing

  • Fluid resistance testing using ASTM F 1862 standard
  • Particulate filtration efficiency using 0.1-Micron Polystyrene Latex Spheres test
  • Bacterial filtration efficiency testing using approved methods
  • Differential pressure (Delta-P) testing for breathability
  • Flammability testing using approved standards (CPSC CS-191-53, NFPA 702-1980, or UL 2154)

Labeling

  • Clear statement of intended use
  • Identification if device is a combination surgical mask/NIOSH certified N95 Respirator
  • Description of indications for use
  • Statement if device is reusable or single-use
  • Flammability warning for Class 3 flammability masks

Biocompatibility

  • Evaluation according to ISO-10993 Part 1 for limited contact devices contacting intact skin

Safety

  • Class 1 and Class 2 flammability materials recommended for operating room use
  • Class 4 flammability materials not appropriate for operating room use

Other considerations

  • ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
  • ASTM F 1862: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood
  • ASTM F2101-01: Standard Test Method for Evaluating the Bacterial Filtration Efficiency
  • CPSC CS-191-53: Standard for Flammability of Clothing Textiles
  • NFPA 702-1980: Standard for Classification of Flammability of Wearing Apparel
  • UL 2154: Test for flame propagation in presence of oxygen

Original guidance

  • Performance Testing and Labeling Requirements for Surgical and Medical Face Masks
  • HTML / PDF
  • Issue date: 2004-03-04
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: abd6f033a8fa9b052e1528152094437e
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