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International Callers: 1-773-799-3847 

Passcode: 4373732
Importing Respirators 

for Health Care Personnel Use 

during COVID-19 Pandemic

• John R. Powers, Jr., Chief, Evaluation and Testing Branch

National Personal Protective Technology Laboratory (NPPTL)

CDC National Institute for Occupational Safety and Health (NIOSH)

• John Verbeten, Acting Deputy Director

Office of Enforcement and Import Operations

FDA Office of Regulatory Affairs (ORA)
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• The FDA will speak about the importation of respirators and 

about their collaboration with CDC on the sampling and 

testing of international respirators in support of the FDA's 

respirator Emergency Use Authorizations.

• The CDC's National Institute for Occupational Safety and 

Health (NIOSH) will describe respirator testing including the 

modified filtration efficiency testing NIOSH completes as part 

of their international respirator assessments.

• Representatives from the FDA, CDC, and OSHA will also 

respond to questions webinar attendees may have about the 

safe use of respirators by healthcare personnel during the 

COVID-19 pandemic.

Agenda
John Verbeten, Acting Deputy Director

Office of Enforcement & Import Operations

FDA Respirator Sampling of

Respirators for Health Care Personnel Use during 

the COVID-19 Pandemic
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Office of the Associate 

Commissioner for 

Regulatory Affairs

Office of 

Management

Office of 

Enforcement and 

Import Operations

Office of 

Partnerships and 

Operational Policy

Office of 

Criminal 

Investigations

Office of Human 

and Animal Food 

Operations

Office of Training, 

Education and 

Development

Office of 

Regulatory Science

Office of Medical 

Products and 

Tobacco 

Operations

Office of 

Communications 

and Project 

Management

Office of Regulatory Affairs
6

Partnership With FDA Centers

and Other Regulatory Partners

ORA

CDER

CVM

CTP CDRH

States/

Other Partners

CBER CFSAN

FDA

Imports Global Presence
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ORA Supports FDA’s Core Business Functions

Pre-Market Review

Consumer & Patient Safety

Assessment of safety and 

effectiveness of new medical 

technology & 

safety of new food 

ingredients

Inspection of manufacturing 

facilities and products to assure 

safety, quality, & compliance 

with FDA regulations

Post-marketing surveillance to 

ensure the safety of consumers 

& patients who use FDAregulated products

Product Safety & Compliance
8

FDA Sampling of Respirators During COVID19

Supporting FDA’s Emergency Use Authorizations

• Sample Non-NIOSH approved respirators 

manufactured in China intended for use as 

respirators in health care settings by health care 

personnel to determine whether they meet the 

expected 95% filtration efficiency level.

• Sampled by FDA and then tested by CDC/NIOSH 

• As set forth in the EUA, any lot or shipment of 

respirators that does not meet the 95% filtration 

efficiency level must not be distributed.
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Summary of 

Emergency Use Authorizations for Respirators

3 Current Respirator EUAs: 

• NIOSH-Approved Air Purifying Respirators for use 

by health care personnel in a Health Care Setting

• Imported Non-NIOSH-Approved Disposable 

Filtering Facepiece Respirators (see Exhibit 1)

• Non-NIOSH-Approved Disposable Filtering 

Facepiece Respirators Manufactured in China 

(see Appendix A)
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Emergency Use Authorization for

Certain Respirators Manufactured in China

Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China

A disposable non-NIOSH-approved respirator manufactured in China is authorized under this EUA if 

it meets any of the following criteria (updated):

1. The respirator is manufactured by an entity that holds one or more NIOSH approvals, that 

have been verified by FDA, for FFRs, and that are produced by the NIOSH approval holder in 

accordance with applicable standards of authorization in another country.

2. The respirator: a) Has a registration certification, reflecting regulatory authorization, under the 

jurisdiction of the Chinese National Medical Products Administration (NMPA) and that is given 

by an appropriate provincial or municipal authority, and that has been authenticated and 

verified by FDA, or b) Conforms to the Personal Protective Equipment (PPE) Directive 

89/686/EEC (for those placed into distribution before April 21, 2019) or that conforms to PPE 

Regulation (European Union (EU) 2016/425 (for those placed into distribution after April 21, 

2019), as evidenced by a CE Mark, and the CE mark has been authenticated and verified by 

FDA.

3. The respirator was previously listed in Appendix A under the April 3, 2020 letter of 

authorization as an authorized respirator because it demonstrated acceptable performance to 

applicable standards as documented by test reports, has had particulate filtration efficiency 

assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) 

TEB-APR-STP-0059 within 45 calendar days of the date of issuance of the May 7, 2020 letter, 

and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency 

greater than or equal to 95 percent. A respirator authorized under this EUA because it meets 

the above criteria (3), is no longer authorized if it has been sampled by FDA, tested by NIOSH 

via a modified version of STP TEB-APR-STP-0059, and results according to NIOSH that 

indicates one or more of the 30 sampled respirators has a filtration efficiency of less than 

95%.
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Emergency Use Authorization for Certain

Respirators Manufactured in China: 

Information about Criterion Three

• Respirators previously listed in Appendix A are eligible 

under criterion three and must:

– Submit information to FDA within 45 days from May 7 

(June 21) as described in the EUA

– Arrange with FDA for sampling of the product.

• As of June 22, 42 Chinese firms have been authorized and 

added to Appendix A via this criterion.
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Sampling

• Manufacturer arranges with FDA, for FDA to collect sample 

of 30 respirators.

– Not importer or U.S. agent

• 30 respirators per sample, collected randomly across all 

lots in shipment of that respirator model.

– Agreed upon between FDA & CDC/NIOSH to provide 

statistically significant results

• Submitted to CDC/NIOSH for analysis using a modified 

version of NIOSH’s Standard Test Procedure (STP) TEBAPR-STP-0059

– Assess filtration efficiency 
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Outcomes

• CDC/NIOSH posts results online

– https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.

html

• Greater than/equal to 95% filtration efficiency 

– May be included in Appendix A under criterion three

• Less than 95% filtration efficiency 

– Will not be included in Appendix A under criterion three 

and 

– The lot or shipment of that model(s) cannot be 

distributed as respirators
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Moving forward • Non-NIOSH Approved Filtering Facepiece Respirators 

Manufactured in China that meet the eligibility criteria in 

the EUA are authorized for use as respirators in health 

care settings by healthcare personnel pursuant to CDC’s 

recommendations.

• Products that do not meet the criteria for eligibility and are 

therefore not authorized under one of the FFR EUAs may 

be eligible for authorization as a face mask for use as 

source control if they meet the criteria for eligibility in the 

Face Mask EUA. 

• FDA expects to continue a level of surveillance sampling 

and testing going forward

For more information: www.cdc.gov/COVID19

International Respirator 

Assessments

John Powers

Branch Chief of the Evaluation and Testing Branch (ETB)

National Institute for Occupational Safety and Health (NIOSH)

National Personal Protective Technology Laboratory (NPPTL)
Where does NPPTL fit into the federal structure?

HHS

CDC

NIOSH

Div/Labs

Department of Health and Human Services

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

NIOSH Divisions/Labs

- National Personal Protective Technology Laboratory
NIOSH Divisions & Laboratories

• Office of the Director, NIOSH

• Division of Field Studies & Engineering (DFSE)

• Division of Safety Research (DSR)

• Division of Science Integration (DSI)

• Division of Compensation Analysis and Support (DCAS)

• Health Effects Laboratory Division (HELD)

• National Personal Protective Technology Laboratory (NPPTL)

• Office of Extramural Programs (OEP)

• Pittsburgh Mining Research Division (PMRD)

• Respiratory Health Division (RHD)

• Spokane Mining Research Division (SMRD)

• Western States Division (WSD)

• World Trade Center Health Program Division (WTC)
NPPTL Organizational Structure

NPPTL Program

Management

Evaluation and Testing

Branch

Conformity Verification and

Standards Development

Branch

• Conformity Assessment

• Respirator Approval

• Engineering Evaluation

• Quality Assurance Evaluation

• Standards Development

• 42 CFR 84

• Consensus Standards

• Policy Development

• Performance Testing

• Product Audit Program

• Site Audit Program

• Product Investigations

• Fielded Equipment Evaluations

• Firefighter Fatality Respirator and 

Clothing Evaluations

• Respiratory Protection

• Protective Clothing & Ensembles

• Human Performance

• Surveillance

• Workplace Interventions

• Outreach

• Scientific Evaluations

• Program Evaluations

• Emergency Response

Research Branch
Conventional Operations: The Respirator Approval 

Program
Conventional Operations: N95 FFR Testing

Standard Test Procedures:

• TEB-APR-STP-0003, Determination of Exhalation Resistance (3 samples)

• TEB-APR-STP-0007, Determination of Inhalation Resistance (3 samples)

• TEB-APR-STP-0059, Determination of Particulate Filter Efficiency Level for N95 Series Filters Against Solid Particulates for 

Non-Powered, Air-Purifying Respirators (20 samples)

TEB-APR-STP-0059 Requirements:

• Pre-condition all 20 samples in humidity chamber at 85% +/- 5% relative humidity for 25 +/- 1 hours.

• Flow Rate of 85 +/- 4 Lpm

• Particle size distribution will be a count median diameter of 0.075 +/- 0.020 micron and a geometric standard deviation not 

exceeding 1.86.

• Aerosol concentration not exceeding 200 mg/m3.

• First 3 samples are fully loaded.

• Remaining 17 samples are loaded according to filter type.
Conventional Operations with COVID-19

+ =
COVID-19 Operations: International Respirators

Comparison of FFP2, KN95, and N95 and 

Other Filtering Facepiece Respirator 

Classes

• U.S.: 42 CFR 84

• Europe: EN-149-2001

• China: GB2626-2006

• Australia/New Zealand: AS/NZ-1716:2012

• Korea: KMOEL-2017-64

• Japan: JMHLW – Notification 214, 2018

Credit: 3M Technical Bulletin, May, 2020, Revision 4

https://multimedia.3m.com/mws/media/1791500O/comparison-ffp2-kn95-n95-filtering-facepiece-respirator-classes-tb.pdf
COVID-19 Operations: International Respirator 

Strategies

Country Performance Standard Acceptable Product Classification

May Be Used in Lieu of 

NIOSH-Certified Products 

Classified as

Australia AS/NZS 1716:2012

P2 N95

P3 N99 or lower

Brazil ABNT/NBR 13698:2011

PFF2 N95

PFF3 N99 or lower

People’s Republic 

of China

GB 2626-2006

GB 2626-2019

GB19083-2010

KN/KP95 N95

KN/KP100 N95

Europe EN 149-2001

P2 N95

P3 N99 or lower

Japan JMHLW-2000

DS/DL2 N95

DS/DL3 N99 or lower

Korea KMOEL-2017-64 Special 1st N95

Mexico NOM-116-2009

N95 N95

R95 R95 or lower

P95 P95 or lower

N99 N99 or lower

R99 R99 or lower

P99 P99 or lower

N100 N100 or lower

R100 R100 or lower

P100 P100 or lower

Respirators Approved Under Standards 

Used in Other Countries That Are Similar 

to NIOSH-Approved N95 Filtering 

Facepiece Respirators
COVID-19 Operations: International Respirators
COVID-19 Operations: International Respirator 

Assessment

Modified Test Procedure:

• Assessment of Filter Penetration Performance for Non-NIOSH Approved Respirators – NPPTL Assessment to Support the 

COVID-19 Response (10 samples)

Modified TEB-APR-STP-0059 Requirements:

• No pre-conditioning.

• Flow Rate of 85 +/- 4 Lpm

• Particle size distribution will be a count median diameter of 0.075 +/- 0.020 micron and a geometric standard deviation not 

exceeding 1.86.

• Aerosol concentration not exceeding 200 mg/m3.

• All 10 samples are run for a 10 minute duration, regardless of filter type.

• Maximum penetration recorded for each respirator.
International Respirator Assessment Results

International Standard Number of Assessments Completed Percent

EN149 27 10%

EN149 and GB2626 48 17%

GB2626 162 57%

GB19083 14 5%

Other 21 7%

UNKNOWN 10 4%

Total 282 100%

Distribution of Completed Assessments by International Standard
International Respirator Assessment Results

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

EN149 EN149 and GB2626 GB2626 GB19083 Other Unknown Overall

Assessment Results by International Standard

≥ 95% ˂ 95%
International Respirator Assessment Results

Ear Loops versus Head Straps/Bands

• 91% have Ear Loops

• Only 9% have Head Straps/Bands

OSHA 1910.134 Requirements

• Must develop and implement a Respiratory Protection Program

• Proper respirator selection, medical evaluations, and training

• Appendix A – Fit Test Procedures

International Respirator Assessment Results 

• https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
Check these additional resources

The NIOSH Certified Equipment List (CEL)

Respirator User Notices

Counterfeit Respirators / Misrepresentation

CDC Crisis Capacity Strategies for Optimizing 

N95s

Understanding the Use of Imported Non- NIOSH-Approved Respirators

Disclaimer: 

Use of trade names and commercial sources is for 

identification only and does not imply 

endorsement by the Centers for Disease Control 

and Prevention or the U.S. Department of Health 

and Human Services.
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Questions?

CDRH-COVID19-SurgicalMasks@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be available 

at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; Sub-heading: Personal 

Protective Equipment (PPE)”

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