Respirator, Surgical
A Surgical Respirator is a medical-grade face mask that provides filtration of airborne particles and surgical aerosols, protecting both patients and healthcare workers from contamination during surgical or clinical procedures. When it is intended to prevent specific diseases or infections, or labeled as filtering surgical aerosols, it is not exempt and is classified as FDA Class 2 requiring 510(k) clearance; a surgical N95 respirator meeting these criteria falls under this classification. The product code is MSH, regulated under 21 CFR 878.4040, reviewed by the General and Plastic Surgery panel. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MSH
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 35 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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 | Jan 12, 2024 | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. |
| K172963 | Master-Frank N95 Particulate Respirator | Apr 04, 2018 | Substantially Equivalent | Master & Frank Enterprise Co., Ltd. |
| K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | Aug 10, 2017 | Substantially Equivalent | 3M Healthcare |
| K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | Jul 15, 2016 | Substantially Equivalent | San-M Package Co., Ltd. |
| 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 | Oct 28, 2015 | Substantially Equivalent | Pasture Pharma Pte, Ltd. |
| K121069 | 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK | Feb 11, 2013 | Substantially Equivalent | 3M Company |
| K102923 | BARRIER N95 PARTICULATE RESPIRATOR | Nov 19, 2010 | Substantially Equivalent | Molnlycke Health Care |
| K102092 | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES | Oct 06, 2010 | Substantially Equivalent | Prestige Ameritech |
| K102173 | MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 | Sep 13, 2010 | Substantially Equivalent | Moldex/Metric, Inc. |
| K100139 | SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 | May 04, 2010 | Substantially Equivalent | Safelife Corp. |
| K092824 | N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 | Oct 21, 2009 | Substantially Equivalent | Alpha Protech, Inc. |
| K090131 | DS N95 SURGICAL MASKS AND FLAT SURGICAL | Apr 27, 2009 | Substantially Equivalent | Shanghai Dasheng Health Products |
| K080827 | HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 | Apr 04, 2008 | Substantially Equivalent | Handan Hengyong Protective & Clean Products Co., L |
| K072067 | N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 | Jan 08, 2008 | Substantially Equivalent | Shuenn Bao Shing Corporation |
| K072359 | AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C | Nov 08, 2007 | Substantially Equivalent | Aearo Company |
| K070692 | DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK | May 30, 2007 | Substantially Equivalent | Dukal Corporation |
| K070168 | N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C | Apr 18, 2007 | Substantially Equivalent | Aearo Company |
| K070782 | WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F | Apr 11, 2007 | Substantially Equivalent | Survivair Respirators, LLC |
| K070139 | WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 | Mar 02, 2007 | Substantially Equivalent | Survivair, Inc. |
| K063023 | 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 | Feb 23, 2007 | Substantially Equivalent | 3M Company |
| K063747 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A | Jan 12, 2007 | Substantially Equivalent | Inovel, LLC |
| K063334 | SHANGHAI GANGHAI MODEL GIKO 1400 | Dec 08, 2006 | Substantially Equivalent | Shanghai Gangkai Purifying Products Co., Ltd. |
| K063013 | PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S | Dec 01, 2006 | Substantially Equivalent | Aearo Company |
| K061375 | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 | Nov 17, 2006 | Substantially Equivalent | Louis M. Gerson Co., Inc. |
| K062665 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | Oct 24, 2006 | Substantially Equivalent | Inovel, LLC |
| K062663 | MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | Oct 11, 2006 | Substantially Equivalent | Moldex/Metric, Inc. |
| K061859 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS | Jul 12, 2006 | Substantially Equivalent | Inovel, LLC |
| K051182 | INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | May 19, 2005 | Substantially Equivalent | Inovel, LLC |
| K050193 | GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR | Apr 11, 2005 | Substantially Equivalent | Louis M. Gerson Co., Inc. |
| K041855 | PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S | Nov 10, 2004 | Substantially Equivalent | Aearo Co. |
| K042267 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP | Sep 30, 2004 | Substantially Equivalent | Inovel, LLC |
| K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | Jul 23, 2002 | Substantially Equivalent | Makrite Industries, Inc. |
| K974068 | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL | Dec 22, 1997 | Substantially Equivalent | Tecnol Medical Products, Inc. |
| K970448 | PCM 2000; ISOLAIR APR MODEL 2735 | Apr 30, 1997 | Substantially Equivalent | Tecnol Medical Products, Inc. |
| K960778 | ISOLAIR APR TYPE N95 | May 09, 1996 | Substantially Equivalent | Louis M. Gerson Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 224 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 224 registration numbers. Click on an entry to view related FDA registrations.