Guidance for Industry and FDA Staff

Surgical Masks - Premarket Notification \[510(k)\] Submissions

**Document issued on: \[release date of FR Notice\]**

**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**This guidance supersedes** "**Draft Guidance for Industry and FDA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 301-443-8913.

![](media/image1.png)**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**

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/%5Bspecific> address\], 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.

Table of Contents

[1. Introduction 1](#introduction)

[2. Background 2](#background)

[3. The Content and Format of an Abbreviated 510(k) Submission
2](#the-content-and-format-of-an-abbreviated-510k-submission)

[4. Scope 4](#scope)

[5. Device Description 5](#device-description)

[6. Risks to Health 6](#risks-to-health)

[7. Fluid Resistance 7](#fluid-resistance)

[8. Filtration Efficiency 8](#filtration-efficiency)

[9. Differential Pressure (Delta-P) Test
8](#differential-pressure-delta-p-test)

[10. Flammability Testing 9](#flammability-testing)

[11. Labeling 10](#labeling)

[Appendix I Abbreviations 11](#appendix-i-abbreviations)

[Appendix II. Summary Report Sample Formats
12](#appendix-ii.-summary-report-sample-formats)

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.***

# 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]{.underline}](http://www.fda.gov/cdrh/modact/leastburdensome.html).

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.

# 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).

# 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 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 device's 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.)

-   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.

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-   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]{.underline}** (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.)

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-   If any part of the device design or testing relies on a recognized
    standard, (1) a statement that testing will be conducted and meet
    specified acceptance criteria before the product is marketed, or (2)
    a declaration of conformity to the standard.[^3] [Please note that
    you must certify that the device is in conformity with the
    standard]{.underline}. (Section 514(c)(1)(B) of the Act.) This means
    that testing must be completed before you submit a declaration of
    conformity. For more information, refer to 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 device's
performance characteristics or information to assess the adequacy of
your acceptance criteria. (Under 21 CFR 807.87(l), we 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.

# 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 user's 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 user's 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**](http://www.cdc.gov/niosh/status.html)
for information about NIOSH\'s Certification Program Support for
Respirator Manufacturers.

# 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.

**Device and Predicate Device Descriptions**

+------------------------+----------------------+----------------------+
| **Description**        | **Your Device**      | **Predicate** (with  |
|                        |                      | 510(k) 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  {#material-composition .unnumbered}

> 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 {#specifications-and-dimensions .unnumbered}

> 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

-   tensile strength

-   other specifications relevant to user needs, e.g., impact resistance

####### Design features {#design-features .unnumbered}

> We recommend that you describe the design features of your mask, such
> as:

-   tie-on or ear loops

-   elastic

-   face shield attached

####### Mask Styles {#mask-styles .unnumbered}

> We recommend that you identify the style of your mask, e.g., duck
> bill, flat pleated, cone shaped, pouch.

# 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            | Section 9                     |
| > (differential pressure)            |                               |
+--------------------------------------+-------------------------------+
| > Flammability                       | Section 10                    |
+--------------------------------------+-------------------------------+
| > Inadequate respiratory barrier for | NIOSH certification           |
| > bacteria                           |                               |
+--------------------------------------+-------------------------------+

Surgical masks include parts that have prolonged contact with intact
skin. We recommend that 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).**

# Fluid Resistance

Fluid resistance is the ability of the mask's 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.  {#according-to-astm-f-1862-surgical-masks-are-tested-on-a-passfail-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. .unnumbered}

# 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 Medium in an Airflow Using
> Latex Spheres.).
>
> **Bacterial Filtration Efficiency**
>
> Bacterial Filtration Efficiency (BFE) is a measure of the ability of
> the mask's 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.

# 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.

**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
  ----------------------------------- -----------------------------------

# 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.

# 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.

# 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.
  ------------ ----------------------------------------------------------

#  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.

+---------------------------+------------------+----------------------+
| **Performance             | **Test Method**  | **Acceptance         |
| Characteristics**         |                  | Criteria or          |
|                           |                  | Results**            |
+---------------------------+------------------+----------------------+
| Fluid Resistance          |                  |                      |
| Performance (mmHg)        |                  |                      |
+---------------------------+------------------+----------------------+
| Particulate Filtration    |                  |                      |
| Efficiency Performance    |                  |                      |
| (%)                       |                  |                      |
+---------------------------+------------------+----------------------+
| Bacterial Filtration      |                  |                      |
| Efficiency Performance    |                  |                      |
| (%)                       |                  |                      |
+---------------------------+------------------+----------------------+
| Differential Pressure     |                  |                      |
| (Delta-P)                 |                  |                      |
|                           |                  |                      |
| (mm H~2~O/cm^2^)          |                  |                      |
+---------------------------+------------------+----------------------+
| Flammability class        |                  |                      |
|                           |                  |                      |
| Class 1                   |                  |                      |
+---------------------------+------------------+----------------------+

For surgical masks that are NIOSH certified N95 Respirators we recommend
the format below.

  --------------------------- ------------------- -----------------------
  **Performance               **Test Method**     **Acceptance Criteria
  Characteristics**                               or Results**

  Fluid Resistance                                
  Performance (mmHg)                              

  Flammability class                              
  --------------------------- ------------------- -----------------------

[^1]: Refer to
    [http://www.fda.gov/cdrh/ode/indicate.html](http://www.fda.gov/cdrh/ode/indicate.pdf)
    for the recommended format.

[^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]{.underline}.

[^4]: In the past, an NFPA test method was used to assess flame-spread
    rate in textile. Although this document was removed from NFPA's list
    of \"active\" standards in 1987, the test is still referenced by
    many submitters.

[^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.