Skip directly to site content Skip directly to search


Español  Other Languages


Centers for Disease Control and Prevention. CDC twenty four seven. Saving Lives, Protecting People
 Search
		×
			NIOSH
			NIOSH
				All CDC
				Submit
			For a full list of topics:A-Z Index
			Advanced Search
		Advanced Search


The National Personal Protective Technology Laboratory (NPPTL)








NIOSH Respiratory Protective Device Information							Updated October 18, 2021
																	Related Pages
					**Subject:** 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in accordance with the Food and Drug Administration Final Rule published May 17, 2018.**This notice has been superseded. For the latest NIOSH guidance on this topic, please see the updated notice:****https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/respprotect/CA-2021-1033-R1.html**NIOSH CA 2021-1033
Revised March 2021
Beginning August 24, 2020, the National Institute for Occupational Safety and Health (NIOSH) began accepting and prioritizing approval applications for surgical N95 filtering facepiece respirators (surgical N95s). Since **NIOSH Approved surgical N95s are also regulated by the Food and Drug Administration (FDA) under product code MSH and 21 CFR 878.4040, this notice informs users about a subset of surgical N95s, exempted by regulation from the FDA’s 510(k) premarket clearance process. This subset of NIOSH Approved surgical N95s are easily identified by the NIOSH approval labels, see Figures 1 and 2.**
NIOSH Approved surgical N95s offer the same level of respiratory protection as a NIOSH Approved N95 filtering facepiece respirator (FFR). Additionally, the surgical N95 has demonstrated conformance to FDA specified flammability, fluid resistance, and biocompatibility requirements and is intended for use in all healthcare settings and for all medical purposes **in which an N95 level of respiratory protection is needed to protect the wearer.**
Users can recognize a **NIOSH Approved surgical N95 by the abbreviated label**, which is printed on each respirator. The surgical N95 abbreviated label includes the name of the approval holder (i.e., name of the company that was issued NIOSH approval), the model or part number, the approval number assigned by NIOSH (e.g., TC-84A-XXXX), “**Surgical N95 Respirator**,” “NIOSH,” and the lot number. An example of an abbreviated label on a NIOSH Approved surgical N95 is shown in Figure 1 below.
The full NIOSH approval label, which is found on, or within the respirator packaging, will indicate the protection type as being “Surgical/N95.” An example of a NIOSH surgical N95 approval label is shown in Figure 2 below. The approval label will have the caution and limitation “S – Special or Critical User Instructions and/or specific use limitations apply. Refer to User Instructions before donning.” The “S” caution and limitation will correspond to a section in the User Instructions that indicates, this respirator has been approved as a NIOSH N95 filtering facepiece respirator, for use in healthcare settings, as a Surgical N95 Respirator conforming to recognized standards for biocompatibility, flammability, and fluid resistance.
NIOSH Approved surgical N95s can be identified on the NIOSH Certified Equipment List (CEL) and can be searched using the term “surgical.”
In addition to surgical N95s approved under the new process, users can select and use a surgical N95 FFR that previously obtained NIOSH approval and FDA 510(k) clearance. The User Instructions and packaging will include the caution and limitation “P – NIOSH does not evaluate respirators for use as surgical masks.” The abbreviated label, which is printed on the respirator, will also **not include** “surgical.” However, NIOSH can approve an approval holder’s updated User Instructions and packaging to **remove** the caution and limitation “P” and **include** caution and limitation “S”. The abbreviated label can also be updated to include “surgical.” It is expected that eventually all Surgical N95s will have consistent labeling and packaging as approval holders submit updates to NIOSH. When the labeling and packaging is updated, these surgical N95 FFRs can also be found on the CEL by using the term “surgical.”**Figure 1: Example of an abbreviated label on a NIOSH Approved surgical N95**
Figure 1: Example of an abbreviated label on a NIOSH Approved surgical N95
**Figure 2: Example of a NIOSH surgical N95 full respirator approval label, often located on or within the packaging.**
Figure 2: Example of a NIOSH surgical N95 full respirator approval label, often located on or within the packaging.
REFERENCES:
FDA Final OrderFDA Postmarket Requirements (Devices)Approval of Respiratory Protective Devices, 42 C.F.R, Part 84MOU 225-18-006NIOSH Conformity Assessment Letter to Manufacturers (CA 2018-1010R1)NIOSH Conformity Assessment Letter to Manufacturers (CA 2020-1031)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. [PDF – 262 KB]
							
					
							Last Reviewed:  October 18, 2021						Source: 	National Institute for Occupational Safety and Health
					Facebook
        Twitter
        LinkedIn
        Syndicate homeNPPTL
What’s New on the NPPTL Websiteplus icon
NPPTL What’s New Archives
A to Z Index
Respiratory Protection Videos
Resources for Mine Workers
Resources for Emergency Responders
Respirator Approval Programplus icon
Respirator Approval Information
Respirator Standards
Respirator User Notices
Resources and Technical Support
Post-market Evaluationsplus icon
PPE CASE Reports
PPE CASE Notes
Respirator Assessments to Support COVID-19 Responseplus icon
Beyond Shelf Life/Stockpiled Assessment Results
International Assessment Results
Decontaminated Assessment Results
Non-NIOSH Approved Innovative Filtering Facepiece Respirator Assessment Results
Protective Clothing and Ensembles
Personal Protective Technology Program
NIOSH Respiratory Protection Week 2023
NPPTL Infographics
NPPTL Fact Sheets
Healthcare Respiratory Protection Resourceplus icon
Policies and Procedures
Program Administrator
Evaluation and Selection
Medical Evaluation
Fit Testing
Proper Use and Storage
Training
Program Evaluation
Recordkeeping
Support for Firefighter Personal Protective Equipmentplus icon
Self-Contained Breathing Apparatusplus icon
Program Overview
Evaluation Process
Completed Reports
Resources
Firefighter Turnout Gearplus icon
Current Projects
Completed Projects
Participation on Standards Setting Organizations
Resources
Considerations for Selecting Protective Clothing
NPPTL Participation in Standard Development Committees
Respiratory Protection Information Trusted Sourceplus icon
Types of Respiratory Protection
Use of NIOSH-approved Respirators
Frequently Asked Questionsplus icon
Respirator FAQs
Fit Test FAQs
NIOSH Approval FAQs
Healthcare Setting Specific FAQs
Approved Particulate Filtering Facepiece Respirators
Certified Equipment List (CEL)
PPE CASE Reports
Respirator User Notices
Meetings, Webinars, & Conferencesplus icon
Archived Meetings and Conferences
Conformity Assessment Notices and Letters to Respirator Manufacturers and Interested Parties
About NPPTL
Contact NPPTL Connect with NPPTL Subscribe to Listserv
PPE concerns? Contact Us
 Follow NIOSH Facebook
Pinterest
Twitter
YouTube
 NIOSH Homepage NIOSH A-Z
Workplace Safety & Health Topics
Publications and Products
Programs
Contact NIOSH


About CDC
					Contact Us
					800-232-4636
 Facebook Twitter Instagram LinkedIn Youtube Pinterest Snapchat
 CONTACT CDC
				Contact Us
							Call 800-232-4636
							Email Us
			ABOUT CDC
				About CDC
							Jobs
							Funding
			POLICIES
				Accessibility
							External Links
							Privacy
							Policies
							No Fear Act
							FOIA
							OIG
							Nondiscrimination
							Vulnerability Disclosure Policy
			CONNECT WITH US
				Facebook
								Twitter
								Instagram
								LinkedIn
							Youtube
								Pinterest
								Snapchat
								Email
			LANGUAGES
				Español
							繁體中文
							Tiếng Việt
							한국어
							Tagalog
							Русский
							العربية
							Kreyòl Ayisyen
							Français
							Polski
							Português
							Italiano
							Deutsch
							日本語
							فارسی
							English


U.S. Department of Health & Human Services
			Accessibility
			External Links
			Privacy
			Policies
			No Fear Act
			FOIA
			Nondiscrimination
			OIG
			Vulnerability Disclosure Policy
			USA.gov


Exit Notification / Disclaimer Policy Close
 Links with this icon  indicate that you are leaving the CDC website. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website.
				Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.
				You will be subject to the destination website's privacy policy when you follow the link.
				CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Website Disclaimers
 Cancel Continue