MSHClass II

Respirator, Surgical

21 CFR 878.4040 / General, Plastic Surgery

MSH is the FDA product code for Respirator, Surgical, a class II device type, regulated under 21 CFR 878.4040. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 35 510(k) clearances under this code, the most recent dated 2024-01-12, and 3 recalls.

Classification record

Product code: MSH
Device name: Respirator, Surgical
FDA 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).
Regulation: 21 CFR 878.4040
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 35
Ingested recalls: 3

Clearances, product code MSH

By decision year

35 clearances under product code MSH with a decision year between 1996 and 2024, 2007 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code MSH by decision year
Year	Clearances
1996	1
1997	2
2002	1
2004	2
2005	2
2006	6
2007	7
2008	2
2009	2
2010	4
2013	1
2015	1
2016	1
2017	1
2018	1
2024	1

Applicants with the most clearances

Product code MSH

Applicants holding the most 510(k) clearances under product code MSH
Applicant	Clearances
Moldex/Metric, Inc.	7
Aearo Company	4
Louis M. Gerson Co., Inc.	3
3M Company	2
Tecnol Medical Products, Inc.	2
3M Healthcare	1
Alpha Protech, Inc.	1
Dukal Corp.	1
Handan Hengyong Protective & Clean Products Co., L	1
Makrite Industries, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 222 companies shown, in name order