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NIOSH-Approved Surgical N95 Respirators
This list is reviewed and updated weekly.
This table of Surgical N95’s is provided as a courtesy. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041. If you have any questions about information contained on this table, contact CDC at 1-800-CDC-INFO (1-800-232-4636).
| Supplier/Manufacturer | Model/Product | Approval Number | User Donning Instructions | |
|---|---|---|---|---|
| 3M Company 888-3M HELPS |
1860 1860S |
84A-0006 | HTML | |
| 1870 | 84A-3844 | PDF – 190 KB | ||
| 1805 | 84A-5469 | PDF – 330 KB | ||
| 1805S | 84A-5470 | PDF – 330 KB | ||
| 1870+ | 84A-5726 | HTML | ||
| 1804 | 84A-7789 | PDF – 298 KB | ||
| 1804S | 84A-7790 | PDF – 298 KB | ||
| Advanced Concept Innovations, LLCexternal icon 863.688.1200 Ext. 7411 |
3120 | 84A-9318 | PDF – 1.7 MB | |
| Aegle PPE 1 LLC 713-364-2363 |
C100S | 84A-9395 | PDF – 233 KB | |
| Aero Pro Company, LTD 886-4-875-6141 |
AP0018 N95 | 84A-4049 | PDF – 63 KB | |
| AP0028 | 84A-4175 | PDF – 65 KB | ||
| AP0708B+ | 84A-9433 | PDF – 197 KB | ||
| AP0028+ | 84A-9454 | PDF – 202 KB | ||
| Alpha Pro Tech 800-749-1363 |
MAS 695 | 84A-0457 | PDF – 211 KB | |
| AMD Medicom, Inc. 800-361-2862, 514-636-6262 |
203214 (Small) 203314 (Medium) 203414 (Large) |
84A-9375 | PDF – 145 KB | |
| Ammex Corporation [*E] 800-379-9929 |
N95F | 84A-4541 | PDF – 5.6 MB | |
| BNX Converting, LLC 713-936-2726 |
SH95W & SH95B | 84A-9523 | PDF – 5.2 MB | |
| BYD Precision Manufacture Co., Ltd. 86-752-511-8888 |
DE2326/Surgical/N95 | 84A-9279 | PDF – 284 KB | |
| Cardinal Health [*E] 800-379-9929 617-964-1365 |
N95-ML | 84A-3323 | PDF – 842 KB | |
| N95-S | 84A-4107 | PDF – 5.6 MB | ||
| N95A-ML | 84A-5411 | PDF – 538 KB | ||
| N95A-S | 84A-5463 | PDF – 538 KB | ||
| Cardinal Health [*Z] 866-401-8972 817-427-2700 |
USA-N95-R | 84A-5527 | PDF – 3.2 MB | |
| Champak Enterprise Company, Ltd.external icon 886-3-3808818 |
SF550 SF550C |
84A-9324 | PDF – 492 KB | |
| SPC520M SPC520L |
84A-9367 | PDF – 269 KB | ||
| Crosstex International [*A] 800-225-8623 |
GMLRESP | 84A-0160 | PDF – 122 KB | |
| GDBRESP | 84A-9317 | PDF – 827 KB | ||
| CVS Pharmacy, Inc. [*E] 800-379-9929 617-964-1365 |
399575 | 84A-5411 | PDF – 586 KB | |
| DCare AG [*E] 800-379-9929 |
RC-10 | 84A-9316 | PDF – 374 KB | |
| Dentec Safety [*E] 888-533-6832 |
AD4N95 | 84A-4541 | PDF – 581 KB | |
| AD2N95A | 84A-5411 | PDF – 538 KB | ||
| Dynarex Corporation [*E] 800-379-9929 617-964-1365 |
2295 | 84A-3323 | PDF – 842 KB | |
| 2296A | 84A-4541 | PDF – 5.5 MB | ||
| 2295A | 84A-5411 | PDF – 538 KB | ||
| Emerald Medical Inc. [*E] 610-670-8571 617-964-1365 |
N9500 | 84A-3323 | PDF – 2.7 MB | |
| Emerald Professional Products [*E] 610-670-8571 617-964-1365 |
N9500A | 84A-5411 | PDF – 586 KB | |
| First Aid Direct [*E] 800-379-9929 |
305050A | 84A-5411 | PDF – 538 KB | |
| FSSC, LLC; DBA Indiana Face Mask (IFM) 219-866-2270 |
SA105 | 84A-9440 | PDF – 256 KB | |
| GlaxoSmithCline Consumer Healthcare [*C] 800-821-7236 800-430-5490 |
ActiProtect UF | 84A-5163 | PDF – 59 KB | |
| Great Hawk Air Service [*E] 800-379-9929 |
GH9500 | 84A-5411 | PDF – 16 MB | |
| Guangzhou Harley Commodity Company Ltd. 86-20-37512950 |
S-108 | 84A-9366 | PDF – 18 MB | |
| S-288S | 84A-9380 | PDF – 17 MB | ||
| S-188N | 84A-9381 | PDF – 17 MB | ||
| GVS Filter Technology UK, Ltd. 39-0516176311 |
Segre N21000S | 84A-9482 | PDF – 1.2 MB | |
| Honeywell International USA (former Sperian) 800-430-5490 USA (former North) 800-430-4110 |
DF365N95HC | 84A-9432 | PDF – 142 KB | |
| Innonix Technologies Limited 632-8737-9898 |
RK-200-3013AN | 84A-7641 | PDF – 662 KB | |
| Inovel, LLC [*J] 800-421-0668 |
1511 1512 1513 1517 Obsolete 08/2009 |
84A-0013 | PDF – 375 KB | |
| Ironwear [*AN] 986-330-3707 |
1524 | 84A-9303 | PDF – 6.4 MB | |
| 1523 | 84A-9323 | PDF – 6.6 MB | ||
| ivWatch, LLC 855-489-2824 |
BLX-9501 | 84A-9379 | PDF – 639 KB | |
| KAWAMOTO CORPORATION [*D] 81-547-45-4125 |
KAWA-001 KAWA-002 |
84A-3348 | PDF – 247 KB | |
| Kimberly-Clark Corporation 800-524-3577 |
46827 46867 Obsolete 7/2021 |
84A-0005 | PDF – 1.1 MB | |
| 46727 46767 Obsolete 7/2021 |
84A-0010 | PDF – 1.1 MB | ||
| Libus of Buenos Aires, Argentinaexternal icon[*A] 800-225-8623 |
1730 | 84A-0160 | PDF – 124 KB | |
| Lighthouse Worldwide Solutions 800-945-5905 |
SHIELD-95-MEDI | 84A-9431 | PDF – 370 KB | |
| Livingstone International Pty, Ltd. [*E] 800-379-9929617-964-1365 |
AP0028-3 | 84A-4175 | PDF – 150 KB | |
| FMN95RN | 84A-5411 | PDF – 538 KB | ||
| Louis M. Gerson Company, Inc. 800-225-8623 |
1730 | 84A-0160 | PDF – 122 KB | |
| 2130 2131 |
84A-4123 | PDF – 122 KB | ||
| 3230+ | 84A-9317 | PDF – 827 KB | ||
| Magid Glove and Safety, LLC [*E] 800-379-9929 617-964-1365 |
910-N95 | 84A-3323 | PDF – 842 KB | |
| Makrite Industries, Inc. 800-379-9929 617-964-1365 |
910-N95 | 84A-3323 | PDF – 842 KB | |
| 910-N95S | 84A-4107 | PDF – 5.6 MB | ||
| 910-N95FMX | 84A-4541 | PDF – 5.6 MB | ||
| 9500-N95 | 84A-5411 | PDF – 538 KB | ||
| 9500-N95S | 84A-5463 | PDF – 615 KB | ||
| SEKURA-X | 84A-9316 | PDF – 885 KB | ||
| 9603S | 84A-9459 | PDF – 812 KB | ||
| FIT+4803 | 84A-9460 | PDF – 403 KB | ||
| 9603 | 84A-9462 | PDF – 812 KB | ||
| Master and Frank Enterprise Co., LTD 886-2-23255066 |
MF-01 | 84A-7697 | PDF – 150 KB | |
| MF-0106 | 84A-9527 | PDF – 305 KB | ||
| Medacure, Inc. [*E] 800-379-9929 617-964-1365 |
9500-N95 / N95-001 | 84A-5411 | PDF – 4 MB | |
| Medegen Medical Product [*AN] 986-330-3707 |
AF999 | 84A-9303 | PDF – 397 KB | |
| Medline Industries, Inc. [*E] 800-379-9929 617-964-1365 |
NON24506 | 84A-3323 | PDF – 842 KB | |
| NON24507 | 84A-4107 | PDF – 5.6 MB | ||
| NON24506A | 84A-5411 | PDF – 538 KB | ||
| NON24507A | 84A-5463 | PDF – 538 KB | ||
| Meditec Japan Company, Ltd. [*P] 886-4-875-6141 |
AP0018-2 | 84A-4049 | PDF – 65 KB | |
| AP0028-2 | 84A-4175 | PDF – 65 KB | ||
| Moldex-Metric, Inc. 800-421-0668 |
1511 1512 1513 1517 |
84A-0013 | PDF – 375 KB | |
| 2210GN95-XS 2211GN95-S 2212GN95-M/L 2217GN95-LP |
84A-4339 | PDF – 375 KB | ||
| 1510 | 84A-5171 | PDF – 375 KB | ||
| 3211N95-S 3212N95-ML 3217N95-LP |
84A-5172 | PDF – 375 KB | ||
| 1712 | 84A-5227 | PDF – 127 KB | ||
| 4150 4151 (Small) |
84A-9392 | PDF – 226 KB | ||
| 4650 (M/L) 4651 (S) |
84A-9444 | PDF – 216 KB | ||
| MYCO Medical Supplies, Inc. [*D] 81-547-45-4125 |
MYTN01-11 Medium | 84A-3348 | PDF – 193 KB | |
| MYTN01-12 Small | 84A-3348 | PDF – 193 KB | ||
| M/s. Magnum Health & Safety Pvt., Ltd. 00-91-8080850482 |
MH 3D PLUS-S | 84A-9428 | PDF – 586 KB | |
| MH CUP-S | 84A-9453 | PDF – 644 KB | ||
| O&M Halyard, Inc. 800-331-4112 |
46827 76827 |
84A-7518 | PDF – 1.4 MB PDF – 1.4 MB |
|
| 46828 | 84A-7519 | PDF – 561 KB | ||
| 46867 76867 |
84A-7520 | PDF – 1.4 MB PDF – 1.5 MB |
||
| 46727 76727 |
84A-7521 | PDF – 1.4 MB PDF – 1.1 MB |
||
| 46728 | 84A-7522 | PDF – 561 KB | ||
| 46767 76767 |
84A-7523 | PDF – 1.5 MB PDF – 1.5 MB |
||
| 62355 | 84A-7524 | PDF – 1.1 MB | ||
| 62126 | 84A-7525 | PDF – 1.1 MB | ||
| Pasture Pharma Pte. Ltd. [*E] 800-379-9929 |
PM10 | 84A-4541 | PDF – 85 KB | |
| PM15 | 84A-5411 | PDF – 112 KB | ||
| Pasture Pharma Pte. Ltd. [*Q] 8886-3-3808818 |
Pasture E520S Pasture E520CS |
84A-7453 | PDF – 1.3 MB PDF – 1.3 MB |
|
| Pasture A520S Pasture A520CS |
84A-7454 | PDF – 3.1 MB PDF – 3.3 MB |
||
| F550S F550CS |
84A-7504 | |||
| Precept Medical Products [*E] 800-379-9929 |
65-3395 | 84A-3323 | PDF – 182 KB | |
| 65-3395S | 84A-4107 | PDF – 182 KB | ||
| 65-3395 | 84A-5411 | PDF – 586 KB | ||
| 65-3395S | 84A-5463 | PDF – 586 KB | ||
| Prestige Ameritech 866-401-8972 817-427-2700 |
RP88020 | 84A-5216 | PDF – 256 KB | |
| USA-N95-S | 84A-5229 | PDF – 1.8 MB | ||
| RP88010 | 84A-5475 | PDF – 187 KB | ||
| USA-N95-R | 84A-5527 | PDF – 3.2 MB | ||
| RP88021 | 84A-9445 | PDF – 165 KB | ||
| Protective Industrial Products. [*E] 800-379-9929 |
270 3000 | 84A-4541 | PDF – 5.6 MB | |
| 270-2000A | 84A-5411 | PDF – 538 KB | ||
| Pyramex Safety Products [*E] 800-379-9929 |
RM10 | 84A-5411 | PDF – 586 KB | |
| Rizhao Sanqi Medical & Health Articles Company, Ltd.external icon 86-633-8537378 x 2178 |
SQ100Sc | 84A-9303 | PDF – 425 KB | |
| Rizhao Sanqi Medical & Health Articles Company, Ltd.external icon 86-633-8537378 x 2178 |
SQ100Gs | 84A-9323 | PDF – 492 KB | |
| Saferun Safety Supplies Co., Ltd. [*A] 800-225-8623 |
SR9502 | 84A-0160 | PDF – 124 KB | |
| SR9501 | 84A-9317 | PDF – 827 KB | ||
| Safety Zone, LLC. [*E] 800-379-9929 |
RS-900-N95A | 84A-5411 | PDF – 538 KB | |
| San-M Package Company, Ltd.external icon 81-547-45-4125 |
TN01-11 TN01-12 |
84A-3348 | PDF – 61 KB | |
| Shanghai Gangkai Purifying Products Company, Ltd. 86-21-5777-5401 |
GIKO 1400 | 84A-4282 | PDF – 78 KB | |
| Shanghai Yunqing Industrial Co., Ltd.400-178-1700 | YQD95H | 84A-9399 | PDF – 158 KB | |
| YQD960H | 84A-9514 | PDF – 307 KB | ||
| Shigematsu Works Company, Ltd. 81-3-6903-7525 |
DD02-N95+S | 84A-9373 | PDF – 1.8 MB | |
| Snowcom Medical Commodity (Guangzhou) Co., Ltd. [*AI]+86-20-36928707 | S-C108 | 84A-9366 | PDF – 16.6 MB | |
| S-C288S | 84A-9380 | PDF – 16.6 MB | ||
| Sperian Respiratory Protection USA, LLC [*C] 800-821-7236 800-343-3411 800-430-5490 |
HC-NB095 | 84A-4357 | PDF – 33 KB | |
| HC-NB295F | 84A-4371 | PDF – 33 KB | ||
| HC-NB095F | 84A-4372 | PDF – 33 KB | ||
| HC-NB295FP | 84A-5667 | PDF – 70 KB | ||
| SteelPro [*A] 800-225-8623 |
1730 | 84A-0160 | PDF – 122 KB | |
| Suzhou Sanical Protective Product Manufacturing Company, Ltd. 86-512-66100068 |
MS8225-S | 84A-9394 | PDF – 258 KB | |
| Venus Safety & Health Pvt., Ltd. 91-022-2769-2646 |
V-4400 SN95 | 84A-9378 | PDF – 1.4 MB | |
| Vitacore Industries Inc. 888-593-2218 |
PT-C99-9500-01M | 84A-9430 | PDF – 1.6 MB | |
| Wurth International Trading America, Inc. [*A] 800-225-8623 |
1730 | 84A-0160 | PDF – 149 KB | |
| Zee Medical, Inc. [*A] 800-225-8623 |
1730 | 84A-0160 | PDF – 122 KB | |
| Zhou Medical Solutions, LLC [*E] 800-379-9929 86-21-5431-3117 (China) |
9500-N95 Z120101 |
84A-5411 | PDF – 587 KB | |
| 9500-N95S Z120102 |
84A-5463 | PDF – 587 KB | ||
| A – Private label of Louis M. Gerson Company, Inc. (800-225-8623) AA – Private label of Foss Manufacturing Company (603-929-6000) AN – Private label of Rizhao Sanqi Medical & Health Articles Co., Ltd. (986-330-3707) 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. (617-964-1365) J – Private label of Moldex-Metric, Inc. (800-421-0668) Q – Private label of Champak Enterprise Company, Ltd. (886-3-3808818) Z – Private Label of Prestige Ameritech (817-427-2700) |
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