NIOSH Respiratory Protective Device

Information

NIOSH CA 2021-1033R1

June 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

regulations at 21 CFR § 878.4040. 

Supersedes March 2021 version 
Document Number

NIOSH CA 2021-1033R1

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Since August 24, 2020, the National Institute for Occupational Safety and Health (NIOSH) has accepted and 

prioritized approval applications for surgical N95 filtering facepiece respirators (surgical N95s), a subset of 

single-use dispoasable N95 filtering facepiece respirators (FFRs). NIOSH-approved N95 FFRs are also regulated 

by the Food and Drug Administration (FDA) as class II devices under 21 CFR § 878.4040, classified as product 

code MSH, and commonly referred to as surgical N95s. This notice is intended to inform users about a subset 

of surgical N95s, exempted by regulation from the FDA’s premarket notification (510(k)) requirements. 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 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 regulations at 21

CFR § 878.4040. 

Supersedes March 2021 version
Document Number

NIOSH CA 2021-1033R1

Page 3 of 5

In addition to surgical N95s approved under the process described above, users can select and use a surgical N95 

FFR that previously received 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. 

Surgical N95s exempt from the 510(k) premarket notification requirements must comply with applicable FDA 

labeling requirements and all other statutory and regulatory requirements. 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 2021-1033R1

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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 2021-1033R1

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REFERENCES:

FDA Final Order

FDA Postmarket Requirements (Devices)

Approval of Respiratory Protective Devices, 42 CFR 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

Revision (R) Date Reason for Revision

1.0 12 May 2021 NIOSH revised this notice based on HHS review and comments.