NIOSH Respiratory Protective Device 

Information

NIOSH CA 2021-1033

March 2021

 

Guidance for respirator users regarding NIOSH Approved surgical N95 

filtering facepiece respirators (surgical N95s) exempt from 510(k) premarket notification in accordance with the Food and Drug Administration 

Final Rule published May 17, 2018.
Document Number

NIOSH CA 2021-1033

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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.”

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.
Document Number

NIOSH CA 2021-1033

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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.” 
Document Number

NIOSH CA 2021-1033

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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. 
Document Number

NIOSH CA 2021-1033

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REFERENCES:

FDA Final Order

FDA Postmarket Requirements (Devices)

Approval of Respiratory Protective Devices, 42 C.F.R, Part 84

MOU 225-18-006 

NIOSH Conformity Assessment Letter to Manufacturers (CA 2018-1010R1) | NPPTL | NIOSH | CDC

NIOSH Conformity Assessment Letter to Manufacturers (CA 2020-1031) | NPPTL | NIOSH | CDC