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				NIOSH-approved N95 Particulate Filtering Facepiece Respirators						Print
																Related Pages
										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    NotesManufacturers Listed Alphabetically – O
Supplier/Manufacturer and Contact Information
Model Number/Product Line
Approval Number
Valve
Yes/No
Manufacturer’s Donning Procedure User InstructionsO & 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]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  ZNotesNotes
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*AM
Private label of Aegle PPE 1 LLC
713-364-2363*AN
Private label of Rizhao Sanqi Medical & Health Articles Co., Ltd.
986-330-3707*AO
Private label of Shenyang Baianda Safety Co., Ltd.
86-24-23412309*AP
Private label of Advanced Concept Innovations, LLC
863-688-1200***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
							
					
							Last Reviewed:  May 12, 2023						Source: 	National Institute for Occupational Safety and Health
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