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).
NOTICE – Donning Procedure User Instructions provided by the Approval Holder or Private Label Entity are currently unavailable. For your filtering facepiece respirator (FFR) to work as effectively as possible, you must wear it correctly. This includes the process of putting it on (donning) and taking it off (doffing). FFRs must form a seal to the face. Fit testing is the best way to confirm that a respirator fits you. View How To Wear Your Filtering Facepiece Respirator for additional information.
Supplier/Manufacturer | Model/Product | Approval Number | User Donning Instructions | |
---|---|---|---|---|
3M Company 888-3M HELPS |
1860 1860S |
84A-0006 | PDF – 258 KB | |
1870 | 84A-3844 | PDF – 190 KB | ||
1805 | 84A-5469 | PDF – 298 KB | ||
1805S | 84A-5470 | PDF – 298 KB | ||
1870+ | 84A-5726 | HTML | ||
1804 | 84A-7789 | PDF – 636 KB | ||
1804S | 84A-7790 | PDF – 636 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 | |
Altor Safety [*A] 800-225-8623 |
62220 | 84A-9317 | PDF – 827 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 | |
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 – 2 MB | |
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 | ||
3330+ | 84A-9582 | PDF – 24.2 MB | ||
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-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 – 228 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 | ||
Medline Industries, LP [*AP] 863-688-1200 |
NON26595 | 84A-9318 | PDF – 3.8 MB | |
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 – 607 KB | |
MH CUP-S | 84A-9453 | PDF – 643 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 | ||
RP88011, RP88021 | 84A-9445 | PDF – 1.2 MB | ||
Profit Royal Pharmaceutical, Ltd. +8520 2387 8926 |
RES-12-A (Small) RES-12-B (Medium) RES-12-C (Large) |
84A-9736 | PDF – 256 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 | ||
SafeSource Direct, LLC 337-210-7920 |
SCR3001 (Small) SCR3002 (Regular) |
84A-9725 | PDF -207 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 – 599 KB | |
Unicharm Corporation [*D] 81-547-45-4125 |
STA-M01 Medium STA-S01 Small |
84A-3348 | PDF – 454 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 | |
Xiantao Zhongyi Safety Protection Products Company, Ltd. 0086-728-3257535/3257635 |
ZY9502S | 84A-9580 | PDF – 161 KB | |
ZY9501S | 84A-9581 | PDF – 219 KB | ||
ZY9503S | 84A-9732 | PDF – 215 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) AP – Private label of Advanced Concept Innovations, LLC, 863-688-1200 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) |