Surgical masks have been a kind of commodity in shortage due to the widespread of 2019-nCoV. There are organizations planning to initiate or expand the production in short time. Surgical masks are classified as medical devices in certain countries with applicable regulations.

As reference information to manufacturers, hereinafter we will make an simple introduction on the FDA Prematket Notification for Surgical Masks to US market, with scope limited to FXX Surgical Mask and MSH Surgical N95 NIOSH certified Respirator described in 21 CFR §878.4040(b) class II.

When submitting the Premarket Notification by a manufacturer, FDA suggests following information to be included in an abbreviated 510(k) submission:


The coversheet should prominently identify the submission as an Abbreviated 510(k).

Proposed Labeling

The labelling should clearly state the intended use. It should also describe the indications for use, such as whether the mask is an isolation mask, procedure mask, or dental face mask. It’s also recommended to state whether your device is intended to be a reusable device or a single use disposable device.

For a Class 3 flammability surgical mask, it’s recommended to include a flammability warning.

Summary report

FDA recommends that the summary report contains a:

a) Description of the device.

FDA recommends to identify the device by regulation and product code and compare the device with the predicate device using a tabular format as shown below.

Description Your Device Predicate (with 510(k) number, if available)
Specifications and Dimensions
Mask Style
Design Feature
NIOSH certification number (when available)

You should also submit an “indications for use” enclosure.

b) Description of device design requirements.

c) Identification of the risk analysis methods used to assess the risk profile as well as the specific device’s design and the results of this analysis.

d) Discussion of the device characteristics that address the risks identified by FDA:

  • inadequate fluid resistance,
  • inadequate barrier for bacteria,
  • inadequate air exchange (differential pressure),
  • flammability
  • inadequate respiratory barrier for bacteria,
  • additional risks identified in the risk analysis.

e) Brief description of the test methods to address each of the following performance aspects:

Performance Aspects Suggested Standard Test Methods
Fluid Resistance ·        ASTM F 1862
Particulate Filtration Efficiency ·        ASTM F 1215-89
Bacterial Filtration Efficiency ·        Mil- M369454C

·        Modified Greene and Vesley Method: Method for evaluation of bacterial filtration efficiency of surgical masks. J Bacteriol 83:663-667. (1962)

·        ASTM F2101-01

Differential Pressure (Delta-P) Test ·        MIL-M-36945C Method 1 Military Specifications: Surgical Mask, disposable (June 12, 1975)
Flammability Testing ·        CPSC CS-191-53 Flammability Test Method (16 CFR 1610)

·        NFPA Standard 702-1980

·        UL 2154

FDA may request additional information about aspects of the device’s performance characteristics or information to assess the adequacy of the acceptance criteria.

QMS Requirements

For the surgical masks to US market, the associated manufactures are required to comply with the Quality System Regulations (21 CFR Part 820), which is quite similar with ISO 13485. For those to some other countries, the manufactures are required or recommended to implement a Quality Management System (QMS) based on ISO 13485 or equivalent standard.

Service by DQS

DQS is a certification body for ISO 13485:2016, a Notification Body for medical devices and CE marking, and an Audit Organization (AO)  providing MDSAP audits.

DQS Academy provides ISO 13485:2016 Internal Auditor Training and Lead Auditor Training courses, to help clients get the required knowledge for medical devices QMS implementation.

Contact us for the service you need.


Referenced Source: Guidance Document by FDA.