non-niosh approved disposable filtering facepiece

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On March 24th in response to the evolving COVID-19 public health emergency and filtering facepiece respirator (FFR) shortages the Food and Drug Administration FDA concluded based on the scientific evidence available that certain imported disposable FFRs that are not National Institute for Occupational Safety and Health (NIOSH) approved are appropriate to protect the public health or safety Use filtering facepiece respirators certified to a foreign standard On March 24 2020 the FDA issued a Non-NIOSH Approved Respirator Emergency Use Authorization allowing use of non-NIOSH-approved respirators in healthcare that have been approved in other countries Respirators not currently on this list may be submitted to the FDA for EUA

Sterilucent Inc Sterilization System

FDA EAU NIOSH approved disposable filtering facepiece respirators with expired shelf life 03/11/2020 Instructions for Healthcare Personnel – 04/11/2020 FDA Manufacturers of Imported Non NIOSH approved disposable filtering facepiece respirators FDA Non NIOSH Approved Respirator EUA FAQ – 03/24/2020

FDA acknowledges in the policy document that it is unable to confirm the authenticity of respirators manufactured to the KN95 standard so the agency recommends that U S importers/distributors be able to demonstrate the authenticity of such respirators through certificates of conformity and test reports (see the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

Imported non-NIOSH-approved Disposable Filtering Facepiece Respirators March 28 2020: NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency March 29 2020: Battelle Decontamination System April 3 2020:

In: Non-NIOSH-approved disposable filtering facepiece respirators manufactured in China - Appendix A: Authorized respirators (2020 Apr 16 cited 2020 Apr 17) 3M | 3M document guidance on finding N95 respirator alternatives: Possible alternatives to surgical filtering facepiece respirators: healthcare (Rev 2 2020 Mar cited 2020 Apr 17)

(May 7 2020) the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria – the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer – and

Instructions for Healthcare Facilities: Requirements for

o Respirators that are authorized by the Non- NIOSH Approved Disposable Filtering Facepiece Respirators manufactured in China EUA and Imported NonNIOSH-Approved Disposable - Filtering Facepiece Respirators • All compatible N95 respirator s used in the TSS 20-CS Decontamination System must be free of visible damage and visual soil/contamination (e g blood dried sputum

FDA Update – Non-NIOSH Approved Disposable Filtering Facepiece Respirators (FFR) 08 May FDA Update – Non-NIOSH Approved Disposable Filtering Facepiece Respirators (FFR) May 8 2020 - 1:37 pm FDA Updates WELL no surprise – this COVID-19 Mask situation is very fluid and the FDA has made another update on what they are allowing to be labeled as a FFR Mask that are not NIOSH approved

Regulations of Personal Protective Equipment (PPE) in Healthcare Settings During the NIOSH-Approved Disposable Filtering Facepiece Respirators • March 28: NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency (Clarification Letter) • April 3: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

For instance the FDA is also reissuing the two EUAs covering imported respirators by tightening criteria in the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China as well as in the Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to not only include new language related to decontamination as noted above but also to revise the Scope of

Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China •Date of First Issuance: 4/03/2020 Authorized respirators should be used in accordance with CDC's recommendations For the most current CDC recommendations on optimizing respirator use please visit CDC's webpage: Strategies for Optimizing the

Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China FDA program to allow non-NIOSH respirators from Australia Brazil EU Japan Korea and Mexico (March 28) No manufacturer has applied for this as of April 16 FDA program to deem all NIOSH-certified respirators as Medical Devices and allowing their use in by healthcare professionals for COVID19 response

Mar 27 2020 Non NIOSH Approved Disposable Filtering Facepiece Respirators The Non NIOSH Approved FFRs EUA only applies to those authorized respirators listed in Exhibit 1 of the EUA or authorized respirators in Exhibit 1 that have been decontaminated In order to be added to Exhibit 1 the respirators must meet one of the two criteria outlined in the Non NIOSH Approved FFRs EUA: Masks

Based on the NIOSH testing FDA revised and reissued its earlier emergency use authorization (EUA) for non-NIOSH-approved disposable filtering facepiece respirators manufactured in China to revise one of the eligibility criteria – the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to FDA by the manufacturer

Guide to decontamination methods for filtering facepiece

As of June 11 2020 the FDA defines compatible N95 respirators as those that are non-cellulose containing respirators that do not have an exhalation valve that are either authorized in the NIOSH-Approved Air Purifying Respirators EUA or is authorized and identified by the FDA's EUA as an imported Non-NIOSH approved disposable filtering facepiece respirator

• Non-NIOSH approved disposable filtering facepiece respirators authorized under March 24 EUA (reissued March 28) • Non-NIOSH approved disposable filtering facepiece respirators made in China approved under April 3 EUA including steps to validate authenticity • Reuse of 510K-cleared respirators with EUA-approved decontamination

Date: April 2020 RE: End User Letter for Non-NIOSH approved FFR Authorized for Use 9320+ and 9322+ Dear Valued Customer This letter relates to the use of the following 3M filtering facepiece respirators (FFR) that have been imported in response to the FFR shortage resulting from the COVID-19 outbreak: 9320+ and 9322+ In its Strategies for Optimizing the Supply of N95 Respirators 1 the U S

Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated Multiple decontamination systems so that they 1) are no longer authorized to decontaminate respirators manufactured in China where applicable and 2) only authorize

Disposable filtering facepiece respirators (such as N95 masks) are discarded when they become unsuitable for further use due to considerations of hygiene excessive resistance or physical damage Elastomeric respirators Elastomeric respirators are reusable devices with exchangeable cartridge filters that offer comparable protection to N95 masks The filters must be replaced when soiled

Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated Multiple decontamination systems so that they 1) are no longer authorized to decontaminate respirators manufactured in China where applicable and 2) only authorize

FDA amends imported non-NIOSH approved respirator emergency use authorization The U S Food and Drug Administration earlier this month reissued its late-March letter of authorization to revise emergency use authorization eligibility criteria for imported non-National Institute for Occupational Safety and Health approved disposable filtering facepiece respirators As a result of the revision

N95 Equivalents as an Alternative to N95 Respirators in a Health Care Setting: Supplemental Information April 7 2020 Mexico who have similar standards to NIOSH On April 3 2020 in response to continued respirator shortages the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China which

FDA Update – Non-NIOSH Approved Disposable Filtering Facepiece Respirators (FFR) May 8 2020 - 1:37 pm FDA Updates WELL no surprise – this COVID-19 Mask situation is very fluid and the FDA has made another update on what they are allowing to be labeled as a FFR Mask that are not NIOSH approved The USA is being the WILD WILD WEST when it is related to the FACE MASK marketing

The Non-NIOSH Approved Disposable KN95 Filtering Facepiece Respirator is designed to help provide respiratory protection for the wearer Heat sealing technology binds 3 layers together to allow for Bacterial Filtration Efficiency (BFE) and Particulate Filtration Efficiency (PFE) ≥ 95% It is also resistant to non-oil based fluids (80mm/Hg) The respirator is designed with non-woven fabric