Skip to main content
Home › Guides › Respirators › Surgical mask vs N95
Guide · Respirators · NIOSH 42 CFR 84 and FDA

Surgical mask vs N95 vs dust mask: what each one is approved to do

A surgical mask is a loose-fitting barrier cleared by the FDA to stop splashes and large droplets and to keep the wearer’s own breath off a patient or a sterile field; it is not designed to protect the wearer from what is in the air, and it leaks around the edges on every breath. An N95 is a respirator approved by NIOSH: it seals to the face, its filter captures at least 95 percent of a hard-to-filter test aerosol, and it must be fit tested and seal checked. A surgical N95 is an N95 that is also FDA-cleared for fluid resistance. A dust mask sold at a hardware store either carries the NIOSH approval and is an N95, or it does not and OSHA does not count it as a respirator at all.

Bayshore Safety. Industrial safety and PPE supplier since 2017. · Current as of October 2026 · 42 CFR Part 84; 29 CFR 1910.134 (current e-CFR); 21 CFR 878.4040; NIOSH/CDC infographic, Understanding the Difference (surgical mask vs N95)
3M Aura N95 Particulate Disposable Respirators3M Aura N95 particulate respiratorNIOSH N95, three-panel flat fold

Why does the seal matter more than the fabric? Air takes the easiest path. If a mask sits loose on the cheeks, most of each breath goes around the material rather than through it, and the filter rating of the material is beside the point. That is the whole difference: a surgical mask’s material can be very good and the mask still protects the wearer poorly, while an N95’s rating only means anything once the seal is proven by a fit test and checked each time it goes on.

What is each one, and who approves it?

From the NIOSH comparison.

Surgical maskCleared by the FDA as a medical device. Loose fit. Tested for fluid resistance, bacterial filtration of the wearer’s exhaled air, and flammability. Protects others and stops splashes. Does not provide the wearer a reliable level of protection from inhaling smaller airborne particles. No fit test; no seal check.
N95 respiratorApproved by NIOSH under 42 CFR 84. Tight fit. Filters at least 95 percent of airborne particles, large and small, non-oil aerosols only. Fit test required before use; user seal check required every time it is put on. Minimal leakage when properly fitted.
Surgical N95Both: NIOSH-approved as an N95 and FDA-cleared for fluid resistance. Health care use where splash and airborne hazards both exist.
Dust mask (no NIOSH mark)A nuisance-dust or comfort mask with no approval. Not a respirator under OSHA; cannot be used where the standard requires one.
KN95, FFP2Foreign standards (China GB 2626, Europe EN 149). Not NIOSH-approved and not acceptable where OSHA requires a NIOSH respirator, outside the emergency use authorizations that have expired.
NIOSH/CDC, Understanding the Difference: surgical mask vs N95 respirator; 42 CFR 84 Subpart K; 21 CFR 878.4040; 29 CFR 1910.134(d)(1)(ii) (NIOSH-certified respirators only).

Which one does OSHA count as a respirator?

Only the NIOSH-approved one. The respiratory protection standard requires the employer to select a NIOSH-certified respirator, used under the conditions of its certification, wherever a respirator is necessary to protect health. A surgical mask or an unapproved dust mask does not meet that rule and cannot be used to control an exposure above a permissible limit. Where the employer allows filtering facepieces for comfort when no hazard exists, the standard’s Appendix D applies, and the mask must still be a respirator to count as one; a surgical mask worn for source control is simply not within the standard.

29 CFR 1910.134(d)(1)(ii); 1910.134(c)(2) and Appendix D (voluntary use).

What does the N in N95 mean, and what else is on the label?

  • N: not resistant to oil. R: somewhat resistant to oil. P: oil proof. The letter says what aerosol the filter was tested against; N-series filters are for dust, mist and fume without oil.
  • 95, 99, 100: the minimum percentage of the test aerosol captured. The test aerosol is sized at the particle the filter is worst at, about 0.3 micrometers, so larger and smaller particles are captured at a higher rate.
  • The NIOSH mark, the approval number (TC-84A-xxxx), the manufacturer and model: all required on the respirator or its packaging. No TC number, no approval.
  • A valve, if present, makes exhaling easier and does nothing for the wearer’s protection; it lets unfiltered breath out, which is why valved N95s are not used for source control or in sterile settings.
42 CFR 84.170 through 84.181 (filter classes and tests); 42 CFR 84.33 (approval labels); NIOSH Certified Equipment List.

How do you tell a real N95 from a counterfeit?

Look for the NIOSH mark, the TC approval number, the manufacturer name and the model on the respirator itself, then check the approval number on the NIOSH Certified Equipment List. Warning signs NIOSH lists: no markings at all, NIOSH spelled wrong, decorative fabric or add-ons, ear loops instead of headbands (only a handful of NIOSH approvals use ear loops; check the number), and claims of approval for children. We buy from the manufacturers and their authorized distributors; every N95 on this page is listed on the CEL under the maker’s own approval.

NIOSH, Counterfeit Respirators / Misrepresentation of NIOSH Approval; NIOSH Certified Equipment List.

NIOSH-approved N95 filtering facepieces

18 items · prices live

Approval number, valve and strap type are as published by the manufacturer on each product page. Sold by the box or case. Contractor Direct orders ship free.

ItemClassPart numberPrice
Moldex 151 Disposable Respirators, N95 Healthcare Particulate Respirators
Moldex 151 N95 Healthcare Particulate RespiratorsClass: N95 · Sold by the pack size
ClassN95Part1513
$48.24
Gerson 1740 Disposable Respirators, N95 Particulate Respirator, Nose and Mouth
ClassN95Part1740
$181.47
Moldex Disposable Respirators, N95 Particulate Respirators
Moldex N95 Particulate RespiratorsClass: N95 · Sold by the pack size
ClassN95Part2200N95
$1.35
Moldex 2400N95 Disposable Respirators, N95 Particulate Respirator, Medium
ClassN95Part2400N95
$64.76
Moldex 2600N95 Disposable Respirators, HandyStrap N95 Particulate Respirator
ClassN95Part2600N95
$38.52
Moldex 2500N95 Disposable Respirators, N95 Particulate Respirator, Two-Strap
ClassN95Part2500N95
$86.72
Moldex 2700N95 Disposable Respirators, HandyStrap N95 Particulate Respirator
ClassN95Part2700N95
$4.40
Moldex 2800N95 Disposable Respirators, HandyStrap N95 Particulate Respirator
ClassN95Part2800N95
$90.04

ItemClassPart numberPrice
Moldex Disposable Respirators, N95 2-Strap Particulate Respirators, Exhale Valve
ClassN95Part2300N95
$3.52
Dynamic 270-RPD714N95 Deluxe N95 Disposable Respirator, Valve, 10 Pack
ClassN95Part270-RPD714N95
$21.99
Portwest P201 Disposable Respirators, N95 Valved Cup Respirator
Portwest P201 N95 Valved Cup RespiratorClass: N95 · Sold by the pack
ClassN95PartP201WHR
$13.99
JSP 272-RPD725N95 Premium N95 Disposable Respirator, Valve, 10 Pack
ClassN95Part272-RPD725N95
$24.49

ItemClassPart numberPrice
Moldex 2310 Disposable Respirators, N99 Premium Particulate Respirator, Medium
ClassN99Part2310
$5.90
3M 8293 Disposable Respirators, P100 Particulate Respirator, Half Facepiece
ClassP100Part8293
$13.35
3M 8233 Disposable Respirators, N100 Particulate Respirator, Half Facepiece
ClassN100Part8233
$11.84
Moldex 4700N100 Airwave N100 Disposable Particulate Respirator
ClassN100Part4700N100
$87.05

P100 and R95 filtering facepieces, and half masks with filters, are in the respirator finder.

Questions people ask

Is a surgical mask a respirator?

No. It is an FDA-cleared barrier that protects others and stops splashes; it is loose-fitting and leaks around the edges, and OSHA does not count it as a respirator.

Is an N95 better than a surgical mask?

For protecting the wearer from what is in the air, yes: it seals and filters at least 95 percent. For keeping the wearer’s breath off a patient, a surgical mask is designed for that job; a surgical N95 does both.

Does a dust mask count as a respirator?

Only if it carries the NIOSH mark and TC number, in which case it is an N95 (or other class). A mask without them is a comfort mask and cannot be used where OSHA requires a respirator.

What is a surgical N95?

An N95 that NIOSH approved and the FDA also cleared for fluid resistance.

Do N95s need to be fit tested?

Yes, before first use and annually, whenever the employer requires them; and a user seal check every time one is put on.

Are KN95 masks NIOSH approved?

No. KN95 is a Chinese standard; it is not acceptable where OSHA requires a NIOSH respirator.

Can I wear an N95 with a beard?

Not where a seal is required; facial hair across the seal fails the fit test and the standard prohibits it (1910.134(g)(1)(i)).

What does the valve on an N95 do?

Lets exhaled air out without going through the filter, for comfort. It does not change the wearer’s protection and is not used where source control matters.

Standards and ratings on this page are as published in the documents named and by the manufacturers named. The employer’s hazard assessment and written program decide what applies at a given workplace. Verify a rating on the product and its spec sheet before use.

Buying N95s by the case?Call (925) 215-7337 or email us and we will quote by approval number. Contractor Direct orders ship free.
Respirator finder
How to buyCard, purchase order or invoice terms; quotes on request; agencies and institutions welcome.
Live Service & SupportReal people who know the products, Monday to Friday 7:30am to 4pm Pacific. 925-215-7337
We DeliverWe ship nationwide. Parcel and LTL freight to job sites and businesses across the U.S.