NIOSH-approved N95 Particulate Filtering Facepiece Respirators

This list is reviewed and updated weekly.

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 Understanding (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. 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).

A respirator labeled as a KN95 respirator is expected to conform to China’s GB2626 standard. NIOSH does not approve KN95 products or any other respiratory protective devices certified to international standards. For more information, view Factors to Consider When Planning to Purchase Respirators from Another Country.
A respirator labeled as a KN95 respirator is expected to conform to China’s GB2626 standard

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.
800-331-4112
46827 & 76827 (FDA) 84A-7518 No 46827 [PDF – 1.43 MB]
76827 [PDF – 1.44 MB]
O & M Halyard, Inc.
800-331-4112
46828 (FDA) 84A-7519 No 46828 [PDF – 561 KB]
O & M Halyard, Inc.
800-331-4112
46867 & 76867 (FDA) 84A-7520 No 46867 [PDF – 1.43 MB]
76867 [PDF – 1.45 MB]
O & M Halyard, Inc.
800-331-4112
46727 & 76727 (FDA) 84A-7521 No 46727 [PDF – 1.4 MB]
76727 [PDF – 1.1 MB]
O & M Halyard, Inc.
800-331-4112
46728 (FDA) 84A-7522 No 46728 [PDF – 561 KB]
O & M Halyard, Inc.
800-331-4112
46767 & 76767 (FDA) 84A-7523 No 46767 [PDF – 1.45 MB]
76767 [PDF – 1.46 MB]
O & M Halyard, Inc.
800-331-4112
62355 (FDA) 84A-7524 No 62355 [PDF – 1.1 MB]
O & M Halyard, Inc.
800-331-4112
62126 (FDA) 84A-7525 No 62126 [PDF – 1.1 MB]
Occupational Safety & Health [*E]
800-379-9929
777-N95S 84A-4107 No 777-N95S [PDF – 5.6 MB]
Omikenshi Company [*D]
81-547-45-4125
4957884135525 84A-3348 No 4957884135525 [PDF – 61 KB]
Optrel Tec Ag
410-398-7240
P.AIR 4190.010 84A-9237 No P.AIR 4190.010 [PDF – 460 KB]
Optrel Tec Ag
410-398-7240
P.AIR CLEAR 4190.020 84A-9434 No P.AIR CLEAR 4190.020 [PDF – 551 KB]
Ourlion Safety Technology (Shenzhen) Co.,Ltd. [*E]
800-379-9929
9600-N95/8295 84A-7867 No 9600-N95/8295 [PDF – 659 KB]
Ourlion Safety Technology (Shenzhen) Co.,Ltd. [*E]
800-379-9929
9600V-N95/8295V 84A-7869 Yes 9600V-N95/8295V [PDF – 659 KB]
Ourlion Safety Technology (Shenzhen) Co.,Ltd. [*E]
800-379-9929
8295S 84A-7871 No 8295S [PDF – 5.4 MB]
Ourlion Safety Technology (Shenzhen) Co.,Ltd. [*E]
800-379-9929
8295C 84A-7882 No 8295C [PDF – 7.5 MB]
Ourlion Safety Technology (Shenzhen) Co.,Ltd. [*E]
800-379-9929
8295VC 84A-7883 Yes 8295VC [PDF – 1.9 MB]
Outdoor Research, LLC
855-967-8197
283036 84A-PH09 No 283036 [PDF – 122 KB]
Outdoor Research, LLC
855-967-8197
283036 84A-PH18 No 283036 [PDF – 122 KB]
OX Group USA, LLC [*E]
800-379-9929
9500-N95 / OX-S242195 84A-5411 No 9500-N95/OX-S242195 [PDF – 659 KB]
OX Group USA, LLC [*E]
800-379-9929
9500V-N95 / OX-S248295 84A-5460 Yes 9500V-N95/OX-S248295 [PDF – 659 KB]
Ozu Corporation [*D]
81-547-45-4125
OZ01-11 84A-3348 No OZ01-11 [PDF – 61 KB]

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. 800-225-8623
*AA Private label of Foss Manufacturing Company 603-929-6000
*AB Private label of Valmy SAS of France (DIV) 1-450-844-3946
*AC Private label of Jiangyin Chang-hung Industrial Manufacturing Factory LLC of China (JCH) 86-510-8691-3080
*AD Private label of Suzhou Sanical Protective Product Manufacturing Company, Ltd 86-512-66100068
*AE Private label of Suzhou Fangtian Industries Co., Ltd. +86 512 65586078 / 65586018
*AF Private label of Venus Safety & Health 91-022-2769-2646
*AG Private label of Xiantao Zhongyi Safety Protection Products +86-728-3257535/3257635
*AH Private label of Air Filtration Solutions, Ltd. 44 (0) 1772 790820 (UK)
*AI Private label of Guangzhou Harley Commodity Company, Ltd. +86-20-36928707
*AJ Private label of GVS Filter Technology UK, Ltd. 44 1524 847600 ext 262 (UK)
*AK Private label of Shining Star Electronic Technology Co., Ltd. +886-3-431-5486
*AL Private label of M/s. Magnum Health & Safety Pvt. Ltd. 00-91-8080850482
*B Private label of Aswan International Corporation 866-2-8369-2525
*C Private label of Honeywell Safety Products 800-430-5490
*D Private label of San M Package Company, Ltd. 81-547-45-4125
*E Private label of Makrite Industries, Inc. 800-379-9929
86-21-5431-3117 (China)
*F Private label of Alpha Pro-Tech 800-749-1363
*G Private label of Kimberly-Clark Corporation 800-524-3577
*H Private label of Willson ® Dalloz Safety Products 800-345-4112
*I Private label of San Huei United Company, Ltd. 886-2-2683-0356
*J Private label of Moldex-Metric, Inc. 800-421-0668
*K Private Label of Shanghai Gangkai Purifying Products Company, Ltd. 86-21-5777-5401
*L Private Label of MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltd.a. 55-11-4070-5999
*M Private Label of Jinfuyu Industrial Company, Ltd. 886-2-2690-2271
*N Private Label of Fido Industrial Safety Masks Manufacturer Company, Ltd. 886-37-741471
*P Private Label of Shuenn Bao Shing Corporation 886-4-875-6141
*Q Private Label of Champak Enterprise Company, Ltd. 886-3-3808818
*V Private Label of Japan Vilene Company, Ltd. 81-3-3258-3355
*Z Private Label of Prestige Ameritech 866-401-8972
Page last reviewed: June 21, 2022