FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K063023 |
3M COMPANY |
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 |
02/23/2007 |
K121069 |
3M COMPANY |
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK |
02/11/2013 |
K171116 |
3M Health Care |
3MÖ VFlexÖ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S |
08/10/2017 |
K041855 |
AEARO CO. |
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S |
11/10/2004 |
K072359 |
AEARO COMPANY |
AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C |
11/08/2007 |
K070168 |
AEARO COMPANY |
N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C |
04/18/2007 |
K063013 |
AEARO COMPANY |
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S |
12/01/2006 |
K092824 |
ALPHAPROTECH, INC. |
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 |
10/21/2009 |
K070692 |
DUKAL CORPORATION |
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK |
05/30/2007 |
K080827 |
HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L |
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 |
04/04/2008 |
K051182 |
INOVEL LLC |
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS |
05/19/2005 |
K042267 |
INOVEL LLC |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP |
09/30/2004 |
K061859 |
INOVEL LLC |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS |
07/12/2006 |
K062665 |
INOVEL LLC |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS |
10/24/2006 |
K063747 |
INOVEL LLC |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A |
01/12/2007 |
K050193 |
LOUIS M. GERSON CO., INC. |
GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR |
04/11/2005 |
K960778 |
LOUIS M. GERSON CO., INC. |
ISOLAIR APR TYPE N95 |
05/09/1996 |
K061375 |
LOUIS M. GERSON CO., INC. |
RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 |
11/17/2006 |
K020474 |
MAKRITE INDUSTRIES, INC. |
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 |
07/23/2002 |
K172963 |
Master & Frank Enterprise Co., Ltd |
Master-Frank N95 Particulate Respirator |
04/04/2018 |
K062663 |
MOLDEX/METRIC, INC. |
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS |
10/11/2006 |
K102173 |
MOLDEX/METRIC, INC. |
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 |
09/13/2010 |
K102923 |
MOLNLYCKE HEALTHCARE |
BARRIER N95 PARTICULATE RESPIRATOR |
11/19/2010 |
K141876 |
PASTURE PHARMA PTE LTD |
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator |
10/28/2015 |
K102092 |
Prestige Ameritech |
PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES |
10/06/2010 |
K100139 |
SAFELIFE CORP. |
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 |
05/04/2010 |
K160271 |
SAN-M PACKAGE CO., LTD. |
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 |
07/15/2016 |
K090131 |
SHANGHAI DASHENG HEALTH PRODUCTS |
DS N95 SURGICAL MASKS AND FLAT SURGICAL |
04/27/2009 |
K063334 |
SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. |
SHANGHAI GANGHAI MODEL GIKO 1400 |
12/08/2006 |
K072067 |
SHUENN BAO SHING CORPORATION |
N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 |
01/08/2008 |
K070782 |
SURVIVAIR RESPIRATORS, LLC |
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F |
04/11/2007 |
K070139 |
SURVIVAIR, INC. |
WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 |
03/02/2007 |
K970448 |
TECNOL MEDICAL PRODUCTS, INC. |
PCM 2000; ISOLAIR APR MODEL 2735 |
04/30/1997 |
K974068 |
TECNOL MEDICAL PRODUCTS, INC. |
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL |
12/22/1997 |