FDA Product Code
FDA Product Code MSH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | Owens & Minor (O&M) Halyard, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K172963 | Master-Frank N95 Particulate Respirator | Master & Frank Enterprise Co., Ltd. | 2018-04-04 | Traditional | PDF ↗ |
| K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | 3M Healthcare | 2017-08-10 | Traditional | PDF ↗ |
| K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | San-M Package Co., Ltd. | 2016-07-15 | Abbreviated | PDF ↗ |
| K141876 | 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 | Pasture Pharma Pte, Ltd. | 2015-10-28 | Traditional | PDF ↗ |
| K121069 | 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK | 3M Company | 2013-02-11 | Traditional | PDF ↗ |
| K102923 | BARRIER N95 PARTICULATE RESPIRATOR | Molnlycke Health Care | 2010-11-19 | Abbreviated | PDF ↗ |
| K102092 | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES | Prestige Ameritech | 2010-10-06 | Abbreviated | PDF ↗ |
| K102173 | MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 | Moldex/Metric, Inc. | 2010-09-13 | Abbreviated | PDF ↗ |
| K100139 | SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 | Safelife Corp. | 2010-05-04 | Traditional | PDF ↗ |
| K092824 | N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 | Alpha Protech, Inc. | 2009-10-21 | Abbreviated | PDF ↗ |
| K090131 | DS N95 SURGICAL MASKS AND FLAT SURGICAL | Shanghai Dasheng Health Products | 2009-04-27 | Abbreviated | PDF ↗ |
| K080827 | HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 | Handan Hengyong Protective & Clean Products Co., L | 2008-04-04 | Abbreviated | PDF ↗ |
| K072067 | N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 | Shuenn Bao Shing Corporation | 2008-01-08 | Traditional | PDF ↗ |
| K072359 | AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C | Aearo Company | 2007-11-08 | Abbreviated | PDF ↗ |
| K070692 | DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK | Dukal Corporation | 2007-05-30 | Traditional | PDF ↗ |
| K070168 | N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C | Aearo Company | 2007-04-18 | Abbreviated | PDF ↗ |
| K070782 | WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F | Survivair Respirators, LLC | 2007-04-11 | Abbreviated | PDF ↗ |
| K070139 | WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 | Survivair, Inc. | 2007-03-02 | Abbreviated | PDF ↗ |
| K063023 | 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 | 3M Company | 2007-02-23 | Abbreviated | PDF ↗ |
| K063747 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A | Inovel, LLC | 2007-01-12 | Traditional | PDF ↗ |
| K063334 | SHANGHAI GANGHAI MODEL GIKO 1400 | Shanghai Gangkai Purifying Products Co., Ltd. | 2006-12-08 | Abbreviated | PDF ↗ |
| K063013 | PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S | Aearo Company | 2006-12-01 | Abbreviated | PDF ↗ |
| K061375 | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 | Louis M. Gerson Co., Inc. | 2006-11-17 | Traditional | PDF ↗ |
| K062665 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | Inovel, LLC | 2006-10-24 | Traditional | PDF ↗ |
| K062663 | MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | Moldex/Metric, Inc. | 2006-10-11 | Abbreviated | PDF ↗ |
| K061859 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS | Inovel, LLC | 2006-07-12 | Abbreviated | PDF ↗ |
| K051182 | INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | Inovel, LLC | 2005-05-19 | Abbreviated | PDF ↗ |
| K050193 | GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR | Louis M. Gerson Co., Inc. | 2005-04-11 | Traditional | PDF ↗ |
| K041855 | PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S | Aearo Co. | 2004-11-10 | Abbreviated | PDF ↗ |
| K042267 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP | Inovel, LLC | 2004-09-30 | Traditional | PDF ↗ |
| K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | Makrite Industries, Inc. | 2002-07-23 | Traditional | PDF ↗ |
| K974068 | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL | Tecnol Medical Products, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K970448 | PCM 2000; ISOLAIR APR MODEL 2735 | Tecnol Medical Products, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K960778 | ISOLAIR APR TYPE N95 | Louis M. Gerson Co., Inc. | 1996-05-09 | Traditional | PDF ↗ |
Product code MSH · Class II · General, Plastic Surgery. Data: openFDA.