Draft Guidance for Industry and FDA Staff

Surgical Masks - Premarket Notification \[510(k)\] Submissions; Draft
Guidance for Industry and FDA

***Draft Guidance***

**This guidance document is being distributed for comment purposes
only.** []{.mark}

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

> Comments and suggestions regarding this draft document should be
> submitted within **\_\_ days** of publication in the *Federal
> Register* of the notice announcing the availability of the draft
> guidance. Submit comments to Dockets Management Branch (HFA-305), Food
> and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
> 20852. All comments should be identified with the docket number listed
> in the notice of availability that publishes in the *Federal
> Register*.

For questions regarding this draft document, please contact Chiu S. Lin,
Ph.D. at 301-443-8913.

**When final, this document supersedes** "**Draft Guidance for Industry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**

![](media/image1.png){width="0.9583333333333334in"
height="1.0729166666666667in"}**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

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)

Draft Guidance for Industry and FDA Staff

Surgical Masks - Premarket Notification \[510(k)\] Submissions; Draft
Guidance for Industry and FDA

***This draft guidance, when finalized, will represent 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 draft guidance document to assist industry in
preparing premarket notification submissions for surgical masks. The
device is intended to be worn by operating room personnel during
surgical procedures to protect both the surgical patients and the
operating room personnel from the transfer of microorganisms, body
fluids, and particulate material. 21 CFR §878.4040.

This draft guidance is issued for comment purposes only. FDA previously
issued a draft guidance entitled "**Draft Guidance for Industry and FDA
Reviewers on the Content and Format of Premarket Notification \[510(k)\]
Submissions for Surgical Mask"** on January 16, 1998; however no notice
of availability was published in the Federal Register. We are seeking to
correct that error by issuing the document again for comment with a
notice of availability in the Federal Register. FDA will consider the
comments received and make every effort to issue the guidance for
implementation in a reasonable time after the comment period has closed.

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 (1) conform to the general controls of the Federal Food, Drug &
> Cosmetic Act (the Act), including the premarket notification
> requirements described in 21 CFR 807 Subpart E, (2) address the
> specific risks to health associated with surgical masks identified in
> this guidance and, (3) obtain a substantial equivalence determination
> from FDA prior to marketing the device. (See also 21 CFR 807.85).

This guidance document identifies the classification regulations and
product codes for the surgical masks (Refer to **Section 4**). In
addition, other sections of this guidance document list the risks to
health identified by FDA and describe measures that, if followed by
manufacturers and combined with the general controls, will generally
address the risks associated with these surgical masks and lead to a
timely premarket notification \[510(k)\] review and clearance.

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.
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 and 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 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:

-   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.

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-   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.)

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-   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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-   A 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 for 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
    testing must be completed before submitting a declaration of
    conformity to a recognized standard]{.underline}. (21 USC
    514(c)(2)(B)). 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>.

If it is not clear how you have addressed the risks identified by FDA or
additional risks identified through your risk analysis, we may request
additional information about aspects of the device's performance
characteristics. We may also request additional information if we need
it 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 can submit a
Traditional 510(k) that provides all of the information and data
required under 21 CFR 807.87 and described in this guidance. 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 Respirator

**Surgical Mask**

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 N95 Respirator**

We recommend that surgical masks with respirator performance features
(Surgical N95 Respirator) also be certified by National Institute of
Occupational Safety and Health (NIOSH) as a respirator.

# 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                 |                      |                      |
|                        |                      |                      |
| (where applicable)     |                      |                      |
+------------------------+----------------------+----------------------+

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:

-   materials your device is made of, e.g., polypropylene

-   weave, e.g., spunbonded, meltblown, or spunbonded

-   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 on the side for blow-by prevention

-   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.

# 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 measures recommended to mitigate these identified risks
are given in this guidance document, as shown in the table below. You
should also conduct a risk analysis, prior to submitting your premarket
notification, to identify any other risks specific to your device. The
premarket notification 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 bacterial filtration   | Section 8                      |
| > efficiency                        |                                |
+-------------------------------------+--------------------------------+
| > Inadequate air exchange           | Section 9                      |
| > (differential pressure)           |                                |
+-------------------------------------+--------------------------------+
| > Flammability                      | Section 10                     |
+-------------------------------------+--------------------------------+

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 effciency performance (Section 8) and differential
pressure (Section 9).**

# Fluid Resistance

Fluid resistance is the ability of the mask's material to inhibit 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 1862-00a: Standard Test Method for Resistance of Surgical
    Mask to Penetration by Synthetic Blood

####### According to ASTM F 1862-00a, 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). Surgical masks that show passing results at these pressures exhibit fluid resistance. Surgical masks that show passing results at higher velocities are more fluid resistant.  {#according-to-astm-f-1862-00a-surgical-masks-are-tested-on-a-passfail-basis-at-three-velocities-corresponding-to-the-range-of-human-blood-pressure-80-120-160-mm-hg.-surgical-masks-that-show-passing-results-at-these-pressures-exhibit-fluid-resistance.-surgical-masks-that-show-passing-results-at-higher-velocities-are-more-fluid-resistant. .unnumbered}

# Filtration Efficiency

For surgical masks that are not certified N95 Respirators, we recommend
that you evaluate filter efficiency performance and bacterial filtration
efficiency. For surgical masks that are certified N95 Respirators, you
may submit your NIOSH certification number in lieu of this information.

> **Filter Efficiency Performance**
>
> 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.
>
> **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 fluid resistance 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 certified N95 Respirators, we recommend
that you evaluate differential pressure. For surgical masks that are
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's material to air flowing through the mask. Pressure
drop also relates to the breathability and comfort of the surgical mask.
We recommend demonstrating Delta-P according to either of the following
standards:

-   MIL-M-36945C 4.4.1.1.1 Method 1 Military Specifications: Surgical
    Mask, disposable (June 12, 1975)

We recommend reporting Delta-P using the comfort scale shown in the
table below.

**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) Flammability
    Test Method

-   NFPA Standard #702-1980: Standard for the use of inhalation
    anesthetics.[^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 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 807.87(e).[^5]

> **Intended Use**
>
> We recommend that you clearly state the intended use of your device,
> and identify whether it is a combination surgical mask 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 include whether your device is intended as
> a single use and disposable device.
>
> **Warning**
>
> For Class 3 flammability surgical mask materials, 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 certified N95 Respirators we recommend
the format below.

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

  Fluid Resistance Performance                     
  (mmHg)                                           

  Filter Efficiency                                
  Performance (microns)                            

  Bacterial Filtration                             
  Efficiency Performance (%)                       

  Differential Pressure                            
  (Delta-P)                                        

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

For surgical masks that are certified N95 Respirators

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

  Fluid Resistance                                
  Performance (mmHg)                              

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

Surgical Mask Guidance

Drafted: F. Marshall 2/26/01

Commented: C. Lin 4/19/02

Revised: F. Marshall 6/22/01

Commented: T. Ulatowski 7/27/01

Revised: F. Marshall 8/3/01

Commented: C. Lin 9/1/01

Revised: F. Marshall 9/7/01

Edited: C. Lin 9/19/01

Revised: F, Marshall 11/21/01

Edited: C. Lin 1/12/-02

Revised: F. Marshall 2/22/02

Edited: C. Lin 6/16/02

Revised F. Marshall 7/26/02

Edited: C. Lin 8/26/02

Revised: F. Marshall 9/23/02

Edited: C. Lin 9/30/02

Revised: F. Marshall 10/17/02

Edited: T. Ulatowski 10/23/02

Edited: T. Ulatowski 12/4/02

Revised: F. Marshall 12/5/02

Final: F. Marshall 1/30/03

Final : Hawthorne 3/3/03

[^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 is 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 applicants.

[^5]: Although final labeling is not required for 510(k) clearance,
    final labeling must comply with the requirements of 21 CFR 801
    before a medical device is introduced into interstate commerce. In
    addition, final labeling for prescription medical devices must
    comply with 21 CFR 801.109. Labeling recommendations in this
    guidance are consistent with the requirements of part 801 and
    section 809.10.