FDA exempted certain class II surgical masks from premarket 
notification requirements, subject to conditions and limitations (83 FR 
22846). Specifically, single-use, disposable respiratory protective 
devices (i.e., N95s) used in a healthcare setting and worn by healthcare 
personnel during procedures to protect both the patient and the 
healthcare personnel from the transfer of microorganisms, body fluids, 
and particulate material that are regulated under procode MSH are 
exempt from premarket notification.  
 
FDA is assessing how to revise this guidance to represent our current 
thinking on this topic. For more information, please contact 
elizabeth.claverie@fda.hhs.gov or the Infection Control Devices Branch 
at 301-796-5580.
  Guidance for Industry and FDA Staff 
 
Surgical Masks - Premarket 
Notification [510(k)] Submissions 
 
 
Document issued on: March 5, 2004 and a correction posted on July 14, 2004. 
 
The draft of this document was issued on May 15, 2003.   
 
This guidance supersedes Draft Guidance for Industry and FDA Reviewers on 
the Content and Format of Premarket Notification [510(k)] Submissions for 
Surgical Mask issued January 16, 1998. 
 
For questions regarding this document, please contact Chiu S. Lin, Ph.D. at 240-276-3700. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Infection Control Devices Branch 
Division of Anesthesiology, General Hospital, 
Infection Control, and Dental Devices 
Office of Device Evaluation  Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration to the 
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments may be submitted to 
http://www.fda.gov/dockets/ecomments.  When submitting comments, please refer to Docket No. 
03D-0137.  Comments may not be acted upon by the Agency until the document is next revised or 
updated. 
 
Additional Copies 
 
Additional copies are available from the Internet at:  
http://www.fda.gov/cdrh/ode/guidance/094.pdf, or CDRH Facts-On-Demand.  In order to 
receive this document via your fax machine, call the CDRH Facts-On-Demand system at 
800-899-0381 or 301-827-0111 from a touch-tone telephone.  Press 1 to enter the system. 
 At the second voice prompt, press 1 to order a document.  Enter the document number 
(094) followed by the pound sign (#).  Follow the remaining voice prompts to complete 
your request. 
    Contains Nonbinding Recommendations 
 
Table of Contents 
 
1.  INTRODUCTION..............................................................................................................................................1 
2.  BACKGROUND................................................................................................................................................2 
3.  THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION..................................2 
4.  SCOPE................................................................................................................................................................5 
5.  DEVICE DESCRIPTION.................................................................................................................................5 
6.  RISKS TO HEALTH.........................................................................................................................................7 
7.  FLUID RESISTANCE.......................................................................................................................................8 
8.  FILTRATION EFFICIENCY..........................................................................................................................8 
9.  DIFFERENTIAL PRESSURE (DELTA-P) TEST.........................................................................................9 
10.  FLAMMABILITY TESTING.......................................................................................................................10 
11.  LABELING.....................................................................................................................................................11 
APPENDIX I ABBREVIATIONS...........................................................................................................................12 
APPENDIX II.  SUMMARY REPORT SAMPLE FORMATS............................................................................13 
 
 
    Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff 
 
 
Surgical Masks - Premarket Notification 
[510(k)] Submissions 
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
 
 
1.  Introduction 
FDA has developed this guidance document to assist industry in preparing premarket notification 
submissions for surgical masks and other masks including isolation masks, procedure masks, and 
dental masks.  These devices may be used by healthcare personnel during procedures to protect 
both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, 
and particulate material.     
 
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe should be 
addressed before your device can be marketed.  In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making.  We also considered 
the burden that may be incurred in your attempt to follow the guidance and address the issues 
we have identified.  We believe that we have considered the least burdensome approach to 
resolving the issues presented in the guidance document.  If, however, you believe that there 
is a less burdensome way to address the issues, you should follow the procedures outlined in 
the A Suggested Approach to Resolving Least Burdensome Issues document.  It is 
available on our Center web page at http://www.fda.gov/cdrh/modact/leastburdensome.html. 
 
    1 Contains Nonbinding Recommendations 
 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
 
2.  Background 
A manufacturer who intends to market a device of this generic type should conform to the 
general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the 
premarket notification requirements described in 21 CFR 807 Subpart E, and obtain a 
substantial equivalence determination from FDA prior to marketing the device.  (See also 21 
CFR 807.81 and 807.87).   
 
This guidance document identifies the classification regulation and product codes for surgical 
masks (refer to Section 4).  In addition, other sections of this guidance document provide 
additional information to manufacturers on addressing risks related to these devices in premarket 
notifications (510(k)s).   
 
This document supplements other FDA documents regarding the specific content requirements 
of a premarket notification submission.  You should also refer to 21 CFR 807.87 and "How to 
Prepare a 510(k) Submission" on FDA Device Advice at 
http://www.fda.gov/cdrh/devadvice/314.html. 
 
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications; Final Guidance, 
http://www.fda.gov/cdrh/ode/parad510.html, a manufacturer may submit a Traditional 510(k) or 
has the option of submitting either an Abbreviated 510(k) or a Special 510(k).  FDA believes an 
Abbreviated 510(k) provides the least burdensome means of demonstrating substantial 
equivalence for a new device, particularly once FDA has issued a guidance document addressing 
that device.  Manufacturers considering modifications to their own cleared devices may lessen 
the regulatory burden by submitting a Special 510(k). 
 
 
3.  The Content and Format of an Abbreviated 510(k) 
Submission  
An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 
807.87, including the proposed labeling for the device sufficient to describe the device, its 
    2 Contains Nonbinding Recommendations 
 
 
intended use, and the directions for its use.  In an Abbreviated 510(k), FDA may consider the 
contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 
807.87(f) or (g); therefore, we recommend that you include a summary report.  The report should 
describe how this guidance document was used during the device development and testing and 
should briefly describe the methods or tests used.  We recommend that you also include a 
summary of the test data or description of the acceptance criteria applied to address the risks 
identified in this document, as well as any additional risks specific to your device.  This section 
suggests information to fulfill some of the requirements of 21 CFR 807.87, as well as some other 
items that we recommend you include in an Abbreviated 510(k). 
 
Coversheet 
The coversheet should prominently identify the submission as an Abbreviated 510(k) and 
cite the title of this guidance document. 
 
Proposed labeling 
Proposed labeling should be sufficient to describe the device, its intended use, and the 
directions for its use.  (Refer to Section 11 for specific information that we recommend you 
include in labeling.) 
 
Summary report 
We recommend that the summary report contain a: 
 
  Description of the device and its intended use.  We recommend that the description 
include a complete discussion of the performance specifications and, when 
appropriate, detailed, labeled drawings of the device.  (Refer to Section 5 for specific 
information that we recommend you include in the device description for devices of 
the types covered by this guidance document.)  You should also submit an 
"indications for use" enclosure.1   
 
  Description of device design requirements.  
 
  Identification of the risk analysis method(s) used to assess the risk profile in general 
as well as the specific devices design and the results of this analysis.  (Refer to 
Section 6 for the risks to health generally associated with the use of this device that 
FDA has identified.) 
 
                                                 
1 Refer to http://www.fda.gov/cdrh/ode/indicate.html for the recommended format. 
 
    3 Contains Nonbinding Recommendations 
 
 
  Discussion of the device characteristics that address the risks identified in this 
guidance document, as well as any additional risks identified in your risk analysis.  
 
  Brief description of the test method(s) you have used or intend to use to address each 
performance aspect identified in Sections 7-10 of this guidance document.  If you 
follow a suggested test method, you may cite the method rather than describing it.  If 
you modify a suggested test method, you may cite the method but should provide 
sufficient information to explain the nature of and reason for the modification.  For 
each test, you may either (1) briefly present the data resulting from the test in clear 
and concise form, such as a table, or (2) describe the acceptance criteria that you will 
apply to your test results.2  (See also 21 CFR 820.30, Subpart C - Design Controls 
under the Quality System Regulation.) 
 
  If you choose to rely on a recognized standard for any part of the device design or 
testing, you may include either a:  
o  statement that testing will be conducted and meet specified acceptance 
criteria before the product is marketed; or   
o  declaration of conformity to the standard.3 
 
Because a declaration of conformity is based on results from testing, we believe you 
cannot properly submit a declaration of conformity until you have completed the 
testing the standard describes.  For more information, please refer to section 
514(c)(1)(B) of the act and the FDA guidance, Use of Standards in Substantial 
Equivalence Determinations; Final Guidance for Industry and FDA, 
http://www.fda.gov/cdrh/ode/guidance/1131.html.  
 
We may request additional information about aspects of the devices performance characteristics 
or information to assess the adequacy of your acceptance criteria.  (Under 21 CFR 807.87(l), we 
                                                 
2 If FDA makes a substantial equivalence determination based on acceptance criteria, the subject 
device should be tested and shown to meet these acceptance criteria before being introduced into 
interstate commerce.  If the finished device does not meet the acceptance criteria and, thus, 
differs from the device described in the cleared 510(k), FDA recommends that submitters apply 
the same criteria used to assess modifications to legally marketed devices (21 CFR 807.81(a)(3)) 
to determine whether marketing of the finished device requires clearance of a new 510(k). 
 
3 See Required Elements for a Declaration of Conformity to a Recognized Standard (Screening 
Checklist for All Premarket Notification [510(K)] Submissions), 
http://www.fda.gov/cdrh/ode/reqrecstand.html. 
 
    4 Contains Nonbinding Recommendations 
 
 
may request any additional information that is necessary to reach a determination regarding 
substantial equivalence.)  
 
As an alternative to submitting an Abbreviated 510(k), you may submit a Traditional 510(k) that 
provides all of the information and data required under 21 CFR 807.87.  A Traditional 510(k) 
should include all of your methods, data, acceptance criteria, and conclusions.  Manufacturers 
considering modifications to their own cleared devices should consider submitting Special 
510(k)s.  
 
 
4.  Scope 
The scope of this document is limited to the following devices described in 21 CFR 
878.4040(b) class II, product codes:  
 
FXX  Surgical Mask  
MSH  Surgical N95 NIOSH certified Respirator  
 
Surgical Mask 
A surgical mask covers the users nose and mouth and provides a physical barrier to fluids and 
particulate materials.  The surgical masks referenced in this guidance document include masks 
that are labeled as a surgical, laser, isolation, dental or medical procedure masks with or without 
a face shield.   
 
Surgical Respirator N95 NIOSH Certified 
A surgical respirator is fitted to the users face, forming a seal that provides a physical barrier to 
fluids, particulate materials, and aerosols.  If you wish to label your device N95 NIOSH 
Certified, please refer to the (NIOSH) website at http://www.cdc.gov/niosh/status.html for 
information about NIOSH's Certification Program Support for Respirator Manufacturers.  
 
5.  Device Description 
We recommend that you identify your device by regulation and product code and compare your 
device with the predicate device using a tabular format as shown in the example below.  We 
recommend that you provide information to show how the new device is both similar to and 
different from the legally marketed device.  Side by side comparisons, whenever possible, are 
desirable.  We also recommend that you describe how any differences may affect the 
comparative safety and performance of the new device. 
    5 Contains Nonbinding Recommendations 
 
 
Device and Predicate Device Descriptions 
Predicate (with 510(k) 
Description  Your Device 
number, if available) 
Materials    
Specifications and dimensions    
Mask style     
Design features      
NIOSH certification number 
  
(when available) 
 
We recommend that you include the following descriptive information in the comparison table: 
 
Material Composition  
We recommend that you describe the material composition of the mask.  A description of 
material composition may include the following: 
 
Type of fabric: 
 
  polypropylene 
  spunbonded, meltblown, or wetlaid. 
 
Other materials: 
 
  metals, for example, used in nose features 
  colorants 
  elastic materials, e.g., used in ear loops 
  foam and other anti-fog materials, if any 
  face shield materials, if any. 
 
Specifications and Dimensions 
We recommend that you provide the following information about your device and any add-
on features such as a face shield or wrap-around visor: 
 
  size 
  dimensions 
    6 Contains Nonbinding Recommendations 
 
 
  tensile strength 
  other specifications relevant to user needs, e.g., impact resistance 
 
Design features 
We recommend that you describe the design features of your mask, such as: 
 
  tie-on or ear loops 
  elastic  
  face shield attached 
 
Mask Styles 
We recommend that you identify the style of your mask, e.g., duck bill, flat pleated, cone 
shaped, pouch. 
 
 
6.  Risks to Health 
In the table below, FDA has identified the risks to health generally associated with the use of the 
surgical masks addressed in this document.  The information we recommend you include in your 
510(k) to address these identified risks are given in this guidance document, as shown in the 
table below.  We recommend that you conduct a risk analysis, before submitting your 510(k), to 
identify any other risks specific to your device.  The 510(k) should describe the risk analysis 
method.  If you elect to use an alternative approach to address a particular risk identified in this 
document, or have identified risks additional to those in this document, you should provide 
sufficient detail to support the approach you have used to address that risk. 
 
Identified risk  Recommended mitigation measures 
Inadequate fluid resistance  Section 7 
Inadequate barrier for bacteria  Section 8 
Inadequate air exchange (differential  Section 9 
pressure) 
Flammability  Section 10 
Inadequate respiratory barrier for bacteria  NIOSH certification 
 
Surgical masks include parts that have prolonged contact with intact skin.  We recommend that 
    7 Contains Nonbinding Recommendations 
 
 
you evaluate the biocompatibility of the materials in these parts as described in the standard ISO-
10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for limited 
contact devices, contacting intact skin.  We also recommend that you document the results in 
your design history file as a part of the Quality Systems Requirements (21 CFR 820.30).  You 
should select tests appropriate for the duration and level of contact with your device.  If identical 
materials are used in a predicate device with the same type and duration of skin contact, you may 
identify the predicate device in lieu of performing biocompatibility testing. 
 
For a surgical mask that is also an N95 Respirator and certified by NIOSH as a respirator, 
you may submit the NIOSH certification number in lieu of filter efficiency performance 
(Section 8) and differential pressure (Section 9). 
 
 
7.  Fluid Resistance 
Fluid resistance is the ability of the masks material to resist the penetration of blood and body 
fluids.  We recommend that you evaluate the fluid resistance of your device using the standard 
listed below. 
 
  ASTM F 1862: Standard Test Method for Resistance of Surgical Mask to Penetration by 
Synthetic Blood 
 
According to ASTM F 1862, surgical masks are tested on a pass/fail basis at three velocities 
corresponding to the range of human blood pressure (80, 120, 160 mm Hg).  Fluid resistance 
may be claimed if the device passes ASTM F1862 at any levels.  Surgical masks that show 
passing results at higher velocities are more fluid resistant.  
 
 
8.  Filtration Efficiency 
For surgical masks that are not NIOSH certified N95 Respirators, we recommend that you 
evaluate filter efficiency performance and bacterial filtration efficiency.  For surgical masks that 
are NIOSH certified N95 Respirators, you may submit your NIOSH certification number in lieu 
of this information. 
Particulate Filtration Efficiency  
We recommend that you conduct a particle challenge study using 0.1-Micron Polystyrene 
Latex Spheres.  This in vitro test challenges the mask with unneutralized 0.1-micron 
polystyrene latex spheres and measures penetration.  The use of latex spheres provides an 
appropriately rigorous test for evaluating a submicron efficiency performance (ASTM F 
1215-89 Standard Test Method for Determining the Initial Efficiency of Flatsheet Filter 
    8 Contains Nonbinding Recommendations 
 
 
Medium in an Airflow Using Latex Spheres.). 
 
Bacterial Filtration Efficiency 
Bacterial Filtration Efficiency (BFE) is a measure of the ability of the masks material to 
prevent the passage of aerosolized bacteria.  BFE is expressed in the percentage of a known 
quantity that does not pass the mask material at a given aerosol flow rate.  We recommend 
that you evaluate the BFE of your device using one of the test methods or standards listed 
below. 
 
  Bacterial Penetration (aerosol filtration) - Mil- M369454C, Military Specifications: 
Surgical Mask, disposable (June 12, 1975). 
 
  Modified Greene and Vesley Method: Method for evaluation of bacterial filtration 
efficiency of surgical masks.  J Bacteriol 83:663-667. (1962). 
 
  ASTM F2101-01 Standard Test Method for Evaluating the Bacterial Filtration 
Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus 
aureus. 
 
 
9.  Differential Pressure (Delta-P) Test 
For surgical masks that are not NIOSH certified N95 Respirators, we recommend that you 
evaluate differential pressure.  For surgical masks that are NIOSH certified N95 Respirators, you 
may submit your NIOSH certification number in lieu of this information. 
Differential Pressure (Delta-P) is the measured pressure drop across a surgical facemask 
material. Delta-P determines the resistance of the surgical facemask to air flowing through the 
mask.  Pressure drop also relates to the breathability and comfort of the surgical mask.  In 
general, a lower Delta-P translates to increased breathability. 
  
  MIL-M-36945C 4.4.1.1.1 Method 1 Military Specifications: Surgical Mask, 
disposable (June 12, 1975) 
 
When reporting Delta-P, report face velocity or sample size and flow rates referencing the test 
method used. 
    9 Contains Nonbinding Recommendations 
 
 
 
Comfort Scale used in Delta-P testing 
Score  Perception 
Above 5.0  hot 
4.0 to 5.0  very warm 
3.0 to 4.0  warm 
2.0 to 3.0  cool 
1.0 to 2.0  very cool 
 
10.  Flammability Testing 
We recommend using one of the standards below to determine the flammability by class. 
 
  CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for Flammability 
of Clothing Textiles  
 
  NFPA Standard 702-1980: Standard for Classification of Flammability of Wearing 
Apparel 4   
 
  UL 2154: Test that measures the level of atmospheric oxygen required to propagate 
flame when ignition is caused by an electrosurgery unit or laser.  Higher levels of oxygen 
required for flame propagation indicate materials which are more flame resistant for 
electrosurgery or laser procedures. 
 
We recommend that Class 1 and Class 2 flammability materials be used in surgical masks 
intended for use in the operating room.   
 
FDA believes that devices with a NFPA Class 4 rating are not appropriate for use in the 
operating room. There are many potential ignition sources in the operating room, including 
surgical lasers, electrosurgical units, endoscopic fiberoptics, and high-energy electro-medical 
devices.  All materials will burn if a high intensity heat source is applied to them, especially in 
the presence of elevated oxygen levels.  
 
                                                 
4 In the past, an NFPA test method was used to assess flame-spread rate in textile.  Although this 
document was removed from NFPAs list of "active" standards in 1987, the test is still 
referenced by many submitters. 
    10 Contains Nonbinding Recommendations 
 
 
11.  Labeling 
The premarket notification should include labeling in sufficient detail to satisfy the requirements 
of 21 CFR 807.87(e).  The following suggestions are aimed at assisting you in preparing labeling 
that satisfies the requirements of 21 CFR Part 801.5 
 
Intended Use 
We recommend that you clearly state the intended use of your device, and identify whether it 
is a combination surgical mask /NIOSH certified N95 Respirator.  We recommend that you 
also describe the indications for use, such as whether the mask is an isolation mask, 
procedure mask, or dental face mask.   
 
We also recommend that you state whether your device is intended to be a reusable device or 
a single use disposable device. 
 
Warning 
For a Class 3 flammability surgical mask, we recommend that you include a flammability 
warning, such as one of the following examples: 
 
This device does not meet 16 CFR 1610, NFPA, or CPSC flammability standards. 
 
This device may burn when used in the presence of high intensity heat source or 
flammable gas. 
 
                                                 
5 Although final labeling is not required for 510(k) clearance, final labeling must comply with 
the requirements of 21 CFR Part 801 before a device is introduced into interstate commerce.  In 
addition, final labeling for prescription devices must comply with 21 CFR 801.109.  Labeling 
recommendations in this guidance are consistent with the requirements of part 801. 
 
    11 Contains Nonbinding Recommendations 
 
 
Appendix I Abbreviations 
 
ASTM  American Society for Testing and Materials 
CDC  Centers for Disease Control and Prevention 
CDRH  Center for Devices and Radiological Health 
CFR  Code of Federal Regulations 
CPSC  Consumer Products Safety Commission 
DSMICA  Division of Small Manufacturers, International and Consumer Assistance 
ISO  International Organization for Standardization    
NFPA  National Fire Protection Association 
NIOSH  National Institute of Occupational Safety and Health   
ODE  Office of Device Evaluation 
OSHA  Occupational Safety and Health Administration 
SMDA  Safe Medical Devices Act of 1990 
UL  Underwriters Laboratory, Inc. 
    12 Contains Nonbinding Recommendations 
 
 
Appendix II.  Summary Report Sample Formats 
You may use the following formats, as applicable to your device, for your summary report.  
Your acceptance criteria may be based on the performance characteristics of a legally marketed 
predicate.  If possible, you should provide the 510(k) number for the predicate.  We recommend 
that the predicate device(s) you choose be as close in intended use, design, and technology to the 
new surgical mask as possible.   
 
For surgical masks that are not NIOSH certified N95 Respirators we recommend the format 
below.   
Acceptance Criteria or 
Performance Characteristics  Test Method 
Results 
Fluid Resistance Performance    
(mmHg) 
Particulate Filtration Efficiency    
Performance (%)  
Bacterial Filtration Efficiency    
Performance (%) 
Differential Pressure (Delta-P)    
(mm H O/cm2) 
2
Flammability class    
Class 1 
 
For surgical masks that are NIOSH certified N95 Respirators we recommend the format below.   
Acceptance Criteria or 
Performance Characteristics  Test Method 
Results 
Fluid Resistance Performance    
(mmHg) 
    13 Contains Nonbinding Recommendations 
 
 
Flammability class     
 
    14