NIOSH-approved N95 Particulate Filtering Facepiece Respirators

Updated October 4, 2021

Manufacturers Listed from A to Z – O

The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. This product filters at least 95% of airborne particles but is not resistant to oil-based particles.

This web page provides a table of NIOSH-approved N95 respirators listed by manufacturer from A-Z. You can find a specific manufacturer by clicking on the first letter of their name on the index below. Web links in the table go to the NIOSH Approval Holder’s website. See the Notes section for information about private labels.

NIOSH entered a Memorandum of Understandingexternal icon (MOU) in 2018 with the Food and Drug Administration (FDA). This MOU granted NIOSH the authority to approve surgical N95 filtering facepiece respirators. Prior to this MOU, both NIOSH and FDA approved and cleared surgical N95s. The Model Number/Product Line in bold text followed by (FDA) indicates these surgical N95 respirators in the table below. NIOSH also provides a table of the surgical N95 respirators approved prior to the MOU. If you believe a surgical N95 respirator is missing from the list, contact the CDC to determine the respirator’s approval status. Call 1-800-CDC-INFO (1-800-232-4636). Also contact the FDA Center for Devices and Radiological Health at 1-800-638-2041 to verify its clearance. Surgical N95 respirators approved under the MOU do not require FDA’s 510(k) clearance. These NIOSH-approved surgical N95 respirators are only on the Certified Equipment List (CEL).

Disclaimer: The links in this section go to websites outside of CDC/NIOSH. These links do not constitute an endorsement of their content, or a statement of NIOSH policy. Nor does the inclusion of the donning procedure or user instructions included on the website and PDF versions.

Index:  3M   A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z    Notes

Manufacturers Listed Alphabetically – O
Supplier/Manufacturer and Contact Information Model Number/Product Line Approval Number Valve
Yes/No
Manufacturer’s Donning Procedure User Instructions
O & M Halyard, Inc.external icon
800-331-4112
46827 & 76827 (FDA) 84A-7518 No 46827 pdf icon[PDF – 1.43 MB]external icon
76827 pdf icon[PDF – 1.44 MB]external icon
O & M Halyard, Inc.external icon
800-331-4112
46828 (FDA) 84A-7519 No 46828 pdf icon[PDF – 561 KB]external icon
O & M Halyard, Inc.external icon
800-331-4112
46867 & 76867 (FDA) 84A-7520 No 46867 pdf icon[PDF – 1.43 MB]external icon
76867 pdf icon[PDF – 1.45 MB]external icon
O & M Halyard, Inc.external icon
800-331-4112
46727 & 76727 (FDA) 84A-7521 No 46727 pdf icon[PDF – 1.4 MB]external icon
76727 pdf icon[PDF – 1.1 MB]external icon
O & M Halyard, Inc.external icon
800-331-4112
46728 (FDA) 84A-7522 No 46728 pdf icon[PDF – 561 KB]external icon
O & M Halyard, Inc.external icon
800-331-4112
46767 & 76767 (FDA) 84A-7523 No 46767 pdf icon[PDF – 1.45 MB]external icon
76767 pdf icon[PDF – 1.46 MB]external icon
O & M Halyard, Inc.external icon
800-331-4112
62355 (FDA) 84A-7524 No 62355 pdf icon[PDF – 1.1 MB]external icon
O & M Halyard, Inc.external icon
800-331-4112
62126 (FDA) 84A-7525 No 62126 pdf icon[PDF – 1.1 MB]external icon
Occupational Safety & Healthexternal icon [*E]
800-379-9929
777-N95S 84A-4107 No 777-N95S pdf icon[PDF – 5.6 MB]external icon
Omikenshi Companyexternal icon [*D]
81-547-45-4125
4957884135525 84A-3348 No 4957884135525 pdf icon[PDF – 61 KB]external icon
Optrel Tec Agexternal icon
410-398-7240
P.AIR 4190.010 84A-9237 No P.AIR 4190.010 pdf icon[PDF – 460 KB]external icon
Ourlion Safety Technology (Shenzhen) Co.,Ltd.external icon [*E]
800-379-9929
9600-N95/8295 84A-7867 No 9600-N95/8295 pdf icon[PDF – 659 KB]external icon
Ourlion Safety Technology (Shenzhen) Co.,Ltd.external icon [*E]
800-379-9929
9600V-N95/8295V 84A-7869 Yes 9600V-N95/8295V pdf icon[PDF – 659 KB]external icon
Ourlion Safety Technology (Shenzhen) Co.,Ltd.external icon [*E]
800-379-9929
8295S 84A-7871 No 8295S pdf icon[PDF – 5.4 MB]external icon
Ourlion Safety Technology (Shenzhen) Co.,Ltd.external icon [*E]
800-379-9929
8295C 84A-7882 No 8295C pdf icon[PDF – 7.5 MB]external icon
Ourlion Safety Technology (Shenzhen) Co.,Ltd.external icon [*E]
800-379-9929
8295VC 84A-7883 Yes 8295VC pdf icon[PDF – 1.9 MB]external icon
Outdoor Research, LLCexternal icon
855-967-8197
283036 84A-PH09 No 283036 pdf icon[PDF – 122 KB]external icon
Outdoor Research, LLCexternal icon
855-967-8197
283036 84A-PH18 No 283036 pdf icon[PDF – 122 KB]external icon
OX Group USA, LLCexternal icon [*E]
800-379-9929
9500-N95 / OX-S242195 84A-5411 No 9500-N95/OX-S242195 pdf icon[PDF – 659 KB]external icon
OX Group USA, LLCexternal icon [*E]
800-379-9929
9500V-N95 / OX-S248295 84A-5460 Yes 9500V-N95/OX-S248295 pdf icon[PDF – 659 KB]external icon
Ozu Corporationexternal icon [*D]
81-547-45-4125
OZ01-11 84A-3348 No OZ01-11 pdf icon[PDF – 61 KB]external icon

Index:  3M   A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z


Notes

Notes
Notes Company Phone Number
*A Private label of Louis M. Gerson Company, Inc.external icon 800-225-8623
*AA Private label of Foss Manufacturing Company 603-929-6000
*AB Private label of Valmy SAS of France (DIV)external icon 1-450-844-3946
*AC Private label of Jiangyin Chang-hung Industrial Manufacturing Factory LLC of China (JCH)external icon 86-510-8691-3080
*AD Private label of Suzhou Sanical Protective Product Manufacturing Company, Ltdexternal icon 86-512-66100068
*AE Private label of Suzhou Fangtian Industries Co., Ltd.external icon +86 512 65586078 / 65586018
*AF Private label of Venus Safety & Healthexternal icon 91-022-2769-2646
*AG Private label of Xiantao Zhongyi Safety Protection Productsexternal icon +86-728-3257535/3257635
*AH Private label of Air Filtration Solutions, Ltd.external icon 44 (0) 1772 790820 (UK)
*AI Private label of Guangzhou Harley Commodity Company, Ltd.external icon +86-20-36928707
*AJ Private label of GVS Filter Technology UK, Ltd.external icon 44 1524 847600 ext 262 (UK)
*AK Private label of Shining Star Electronic Technology Co., Ltd.external icon +886-3-431-5486
*B Private label of Aswan International Corporationexternal icon 866-2-8369-2525
*C Private label of Honeywell Safety Productsexternal icon 800-430-5490
*D Private label of San M Package Company, Ltd.external icon 81-547-45-4125
*E Private label of Makrite Industries, Inc.external icon 800-379-9929
86-21-5431-3117 (China)
*F Private label of Alpha Pro-Techexternal icon 800-749-1363
*G Private label of Kimberly-Clark Corporationexternal icon 800-524-3577
*H Private label of Willson ® Dalloz Safety Productsexternal icon 800-345-4112
*I Private label of San Huei United Company, Ltd.external icon 886-2-2683-0356
*J Private label of Moldex-Metric, Inc.external icon 800-421-0668
*K Private Label of Shanghai Gangkai Purifying Products Company, Ltd.external icon 86-21-5777-5401
*L Private Label of MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltd.a.external icon 55-11-4070-5999
*M Private Label of Jinfuyu Industrial Company, Ltd.external icon 886-2-2690-2271
*N Private Label of Fido Industrial Safety Masks Manufacturer Company, Ltd.external icon 886-37-741471
*P Private Label of Shuenn Bao Shing Corporationexternal icon 886-4-875-6141
*Q Private Label of Champak Enterprise Company, Ltd.external icon 886-3-3808818
*V Private Label of Japan Vilene Company, Ltd.external icon 81-3-3258-3355
*Z Private Label of Prestige Ameritechexternal icon 866-401-8972
Page last reviewed: October 4, 2021