Conformity Assessment Notices and Letters to Manufacturers and Interested Parties

NIOSH Respiratory Protective Device Information

Guidance documents developed to inform respiratory protective device users.

CA 2024-1077 – Effective Immediately: Voluntary Rescission of nine Aswan International Corp. Approvals

CA 2024-1076 – Effective Immediately: Voluntary Rescission of one Makrite Industries, Inc. Approval

CA 2024-1075 – Effective Immediately: Voluntary Rescission of six Masprot S.C., EI. LTDA Approvals

CA 2024-1074 – Effective Immediately: Voluntary Rescission of eight Masprot S.C., EI. LTDA Approvals

CA 2024-1073 – Effective Immediately: Voluntary Rescission of Two Honeywell International Inc. Approvals

CA 2024-1072 – Effective Immediately: Voluntary Rescission of one A & Z Pharmaceutical, Inc. Approval

CA 2023-1071 – Effective Immediately: Voluntary Rescission of 48 Honeywell International Inc. Approvals

CA 2023-1070 – Effective Immediately: Voluntary Rescission of 26 Honeywell International Inc. Approvals

CA 2023-1069 – Effective Immediately: Voluntary Rescission of 12 AOK Tooling Limited Approvals

CA 2023-1068 – Effective Immediately: Voluntary Rescission of 30 Dentec Safety Specialists Corp. Approvals

CA 2023-1067 – Effective Immediately: Voluntary Rescission of 19 Honeywell International, Inc. Approvals

CA 2023-1066 – Notice: Important reminder to use the approved carry case for the Ocenco M-20.3 Closed-Circuit Escape Respirator (CCER)

CA 2023-1065 – Effective Immediately: Voluntary Rescission of three Walter Surface Technologies Approvals

CA 2023-1064 – Effective Immediately: Voluntary Rescission of one Air Filtration Solutions Ltd. Approval

CA 2023-1063 – Effective Immediately: Voluntary Rescission of one Merilogy Inc. Approval

CA 2023-1060 – Effective Immediately – Effective Immediately: Voluntary Rescission of Honeywell International Inc. Approval

CA 2023-1059 – Effective Immediately — Revocation of NIOSH Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, Supersedes NIOSH CA 2022-1044

CA 2023-1057 – Effective Immediately: Voluntary Rescission of 24 E.D. Bullard Company Respirator Approvals

CA 2023-1055 – Effective Immediately: Voluntary Rescission of certain Honeywell International Inc. Approvals

CA 2023-1053 – Clarification of label information for Self-Contained Breathing Apparatus that are approved by NIOSH and certified to the National Fire Protection Association (NFPA) 1981 standard, 2019 Edition

CA 2023-1052R1 – Effective Immediately: Revocation of LiveFree Personal Protection LLP Approval, Supersedes CA 2023-1052

CA 2023-1052 – Effective Immediately: Rescission of LiveFree Personal Protection LLP Approval

CA 2023-1051 – Effective Immediately: Voluntary Rescission of RB Sigma, LLC Approval

CA 2022-1049 – Revocation of Seven Honeywell Int’l. Inc. SAF-T-FIT Approvals Labeled as Sperian Products

CA 2022-1048 – Effective Immediately: Voluntary Rescission of Supplied Air Monitoring Systems, Inc. Approval

CA 2022-1047 – A NIOSH-approved respirator cannot be altered to improve fit. Superseded notice NIOSH CA 2021-1037

CA 2022-1044 – Immediate information for respirator users regarding NIOSH Public Health Emergency (PHE) Approvals issued during the COVID-19 Response and the action to obsolete (phase out) these PHE approvals

CA 2022-1043 – Effective Immediately: Voluntary Rescission of Pacific PPE Corporation Approvals

CA 2022-1042 – Effective Immediately: Voluntary Rescission of ALG Health Approvals

CA 2021-1038 – Revocation of Shanghai Dasheng Health Products Manufacture Co., Ltd. Approvals

CA 2021-1037 – Updated user instruction information regarding three NIOSH-approved filtering facepiece respirators TC-84A-9298, TC-84A-9308 and TC-84A-9315

CA 2021-1033R1 – Guidance for respirator users regarding NIOSH Approved surgical N95 filtering facepiece respirators (surgical N95s) exempt from 510(k) pre- market notification in accordance with the Food and Drug Administration regulations at 21 CFR § 878.4040. Supersedes March 2021 version

CA 2021-1035 – Revocation of Public Health Emergency Approval TC-84A-PH19

CA 2021-1033 – Guidance for respirator users regarding NIOSH Approved surgical N95 filtering facepiece respirators (surgical N95s) exempt from 510(k) pre-market notification in accordance with the Food and Drug Administration Final Rule published May 17, 2018

CA 2020-1028 – Information regarding damaged or degraded head straps on previously stockpiled NIOSH-approved filtering facepiece respirators

CA 2020-1026 – Information regarding Shanghai Dasheng Health Products Manufacture Co., Ltd. (SDH) filtering facepiece respirators (FFRs) with ear loops and labeled as NIOSH-approved

CA 2018-1006R1 – Self-contained breathing apparatus (SCBA) user information regarding compressed breathing gas containers (cylinders), NIOSH approval holder user instructions, and Department of Transportation (DOT) permit and marking. Revised: Supersedes the August 2018 version Additional information: Pipeline and Hazardous Materials Safety Administration Notice: DOT Special Permit 16320

CA 2018-1006 – Self-contained breathing apparatus user information regarding compressed breathing gas containers (cylinders), NIOSH approval holder user instructions, and Department of Transportation (DOT) permit and marking

NIOSH Conformity Assessment Notice

Document developed to provide information to NIOSH approved respirator users (formerly called user notices), to inform stakeholders about changes in a test procedure or the NIOSH CA process, revocations (formerly referred to as letters to interested parties). The document developed to reaffirm a NIOSH CA process or procedure.

CA 2023-1054 – DEVCOM Chemical Biological Center (CBC) Fees for Chemical Warfare Agent (CWA) Testing, effective March 2023. This notice supersedes NIOSH Conformity Assessment Notice NIOSH CA 2019-1023 and the NIOSH Letter to All Manufacturers dated August 22, 2014

CA 2021-1034R1 – Summarized Information about NIOSH Respirator Approval Program (i) Basic Application Procedures (ii) Quality Assurance Requirements and (iii) Supplier or Subcontractor Agreements. Supersedes: March 2021 version

CA 2021-1034 – Summarized Information about NIOSH Respirator Approval Program (i) Basic Application Procedures (ii) Quality Assurance Requirements and (iii) Supplier or Subcontractor Agreements

CA 2019-1016 – Summary of the Federal Register comments concerning the Department of Transportation Special Permit 16320 Additional information: Pipeline and Hazardous Materials Safety Administration Notice: DOT Special Permit 16320

CA 2019-1012 – NIOSH Respirator Approval Contents and Meaning, Supersedes: March 17, 2006 Respirator User Notice – Meaning of NIOSH Approvals May 15, 2015 Letter to All Respirator Manufacturers – NIOSH Respirator Certificate of Approval, Approval Labels and User Instructions

CA 2018-1003 – NIOSH Use of a Personal Computer (PC) Based System, Microsoft Windows and National Instruments’ LabVIEW™ Data Acquisition Software to replace use of the Gould RS3200 Strip Chart Recorder beginning June 15, 2018

CA 2018-1002 – Intra-Laboratory Comparison of LabVIEW™ Data Acquisition Software to replace use of the Gould RS3200 Strip Chart Recorder

NIOSH Conformity Assessment Interpretation

An explanation of a course of action or position adopted and pursued by NIOSH/NPPTL that directly affects its stakeholders such as interpretations of and changes to the respirator approval process or requirements.

CA 2021-1039 – NIOSH Respirator Approval Program’s use of the NIOSH Bivariate Panel during Laboratory Respirator Protection Level Testing of Chemical, Biological, Radiological, and Nuclear (CBRN) Self-Contained Breathing Apparatus, CBRN Air-Purifying Respirators, and CBRN Powered Air-Purifying Respirators beginning November 15, 2021

CA 2019-1019 – Effective Immediately – NIOSH quality control plan requirements

CA 2019-1017 – NIOSH acceptance of breathing gas cylinders marked in accordance with 49 C.F.R. Part 178 and ISO 11119-2

CA 2019-1013 – NIOSH labeling requirements for air-purifying and powered air-purifying respirators, effective March 1, 2019. Supersedes the July 19, 1995 Letter to All Respirator Manufacturers

CA 2019-1011 – NIOSH Respirator Approval Program’s use of the NIOSH Bivariate Panel during Isoamyl Acetate Fit Testing beginning February 1, 2019, Supersedes: May 18, 2005 Letter to All Respirator Manufacturers

CA 2018-1005R1.0 – NIOSH Respirator Approval Program’s updated position regarding facial hair and the selection and use of respiratory protective devices. Revised – Supersedes the August 2018 version and the October 2, 2006 Letter to All Respirator Manufacturers

CA 2018-1005 – NIOSH Respirator Approval Program’s updated position regarding facial hair and the selection and use of respiratory protective devices, Supersedes October 2, 2006 Letter to All Respirator Manufacturers

NIOSH Conformity Assessment Letter to Manufacturers

Documents formerly referred to as Letters to All Manufacturers.

CA 2024-1078 – Temporary Delays in Applications that Require Human Test Participants

CA 2023-1062 – Information and Responsibilities of NIOSH Approval Holders for Nonconforming Respirator Investigations (NRIs)

CA 2023-1061 – Effective Immediately — NIOSH Respirator Approval Program Returns to Conventional Operations. This notice supersedes NIOSH CA 2022-1040.

CA 2023-1058 – Effective Immediately — Revocation of Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, Supersedes NIOSH CA 2022-1045

CA 2023-1056 – NIOSH fraud and fraudulent statements policy and information about the NIOSH Respirator Approval Program certification marks. This notice supersedes NIOSH CA 2022-1041-R1.

CA 2022-1050 – Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals

CA 2022-1041-R1 – Effective Immediately – NIOSH fraud and fraudulent statements policy and new information about using NIOSH marks. This notice and NIOSH CA 2022-1040 supersede NIOSH CA 2022-1041 and NIOSH CA 2021-1032

CA 2022-1045 – Updated Information for NIOSH-Approval Holders having Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, and the NIOSH action to obsolete (phase out) these PHE approvals. Supersedes NIOSH CA 2021-1036

CA 2022-1041 – Effective Immediately – NIOSH fraud and fraudulent statements policy and new information about using NIOSH marks. This notice and NIOSH CA 2022-1040 supersede NIOSH CA 2021-1032

CA 2022-1040 – Effective Immediately – Prioritization of applications submitted by existing domestic approval holders and new domestic applicants for new approvals or extensions-of-approval for particulate filtering respirators, including Surgical N95 respirators. This prioritization does not include private-label requests. This notice and NIOSH CA 2022-1041 supersede NIOSH CA 2021-1032

CA 2021-1036 – Immediate Information for NIOSH-Approval Holders having Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, and the forthcoming NIOSH revocation of these PHE approvals

CA 2021-1032 – Effective Immediately – In response to COVID-19 – Updated NIOSH fraud and fraudulent statements policy and prioritization for accepting and examining particulate filtering respirator approval applications, including Surgical N95 respirators, submitted by existing domestic and non-domestic approval holders, new domestic manufacturers/applicants, and new non-domestic manufacturers/applicants. Supersedes NIOSH CA 2020-1031

CA 2020-1031 – Effective Immediately – In response to COVID-19 – UPDATED NIOSH prioritization for accepting and examining particulate filtering respirator approval applications, including Surgical N95 respirators, submitted by existing approval holders, new domestic manufacturers/applicants, and new international manufacturers/applicants. Supersedes NIOSH CA 2020-1027

CA-2020-1030 – Requirements and Responsibilities of Approval Holders and Assignees in NIOSH Approved Respirator Private Labeling and Private Packaging Arrangements

CA 2020-1029 – Clarification about U.S. Food and Drug Administration (FDA) Emergency Use Authorizations (EUA) Applicable to Existing NIOSH Respirator Approval Holders

CA 2020-1027 – Effective Immediately – In response to COVID-19 – NIOSH is accepting and prioritizing particulate filtering respirator approval applications submitted by existing approval holders and new domestic manufacturers/applicants. Supersedes NIOSH CA 2020-1024

CA 2020-1025 – Effective immediately – NIOSH Approval Letters, Denial Letters, and Final Fee Invoices will be signed electronically

CA 2020-1024 – Effective immediately – NIOSH is prioritizing Respirator Approval Applications in response to COVID-19

CA 2019-1023 – Revised Chemical Warfare Agent (CWA) Test Fees, Fee Collection Process, and submission Requirements for NIOSH CBRN Respirator Approvals, effective January 1, 2020, this notice supersedes NIOSH CA 2018-1009 and the NIOSH Letter to All Manufacturers dated August 22, 2014

CA 2019-1022 – Interim Resolution to Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals, supplements CA-2019-1018 and 1021

CA 2019-1021 – Interim Resolution to Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals, supplements CA-2019-1018

CA 2019-1018 – Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals

CA 2019-1015 – Resolution to Issue Affecting Gas and Vapor Testing for NIOSH Respirator Approvals, supersedes NIOSH CA 2019-1014

CA 2019-1014 – Issue Affecting Gas and Vapor Testing for NIOSH Respirator Approvals

CA 2018-1010R1.0 – Interim guidance regarding applications for NIOSH Approval of Filtering Facepiece Respirators in accordance with the Food and Drug Administration (FDA) Final Order published May 17, 2018, and FDA/NIOSH MOU 225-18-006, dated November 2017 (included as a reference in this notice). Revision Supersedes the November 2018 version

CA 2018-1010 – Interim guidance regarding applications for NIOSH Approval of Filtering Facepiece Respirators in accordance with the Food and Drug Administration (FDA) Final Order published May 17, 2018, and FDA/NIOSH MOU 225-18-006, dated November 2017 (included as a reference in this notice)

CA 2018-1009 – Revised Chemical Warfare Agent (CWA) Test Fees for NIOSH CBRN Respirator Approvals, effective October 10, 2018, this notice supersedes NIOSH Letter to All Manufacturers dated August 22, 2014

CA 2018-1008 – Resolution to Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals, supersedes NIOSH CA 2018-1001

CA 2018-1001 – Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals

NIOSH Conformity Assessment Meeting

A meeting announcement to advertise date, time and attendance instructions for interested parties.

CA 2022-1046 – Meeting with Respirator Approval Holders, September 7, 2022, 9:00 AM – 3:00 PM EST, Virtual via Zoom

CA 2019-1020 – Meeting with Respirator Manufacturers, October 29, 2019, 9:00 AM – 4:00 PM EST, NIOSH Pittsburgh Facility, Building 140 Multipurpose Room or by Adobe Connect

CA 2018-1007 – Meeting with Respirator Manufacturers, October 17, 2018, 9:00 AM – 4:00 PM EST, NIOSH Pittsburgh Facility, Building 140 Multipurpose Room or by Adobe Connect

CA 2018-1004 – Meeting with Respirator Manufacturers, August 7, 2018, 9AM – 2PM EST, NIOSH Pittsburgh Facility, Building 140 Multipurpose Room

Below are letters issued to respirator manufacturers and letters issued to all interested parties: