MSH · Class II · 21 CFR 878.4040

FDA Product Code MSH: Respirator, Surgical

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).

Leading manufacturers include Owens & Minor (O&M) Halyard, Inc..

35
Total
35
Cleared
97d
Avg days
1996
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Respirator, Surgical Devices (Product Code MSH)

35 devices
1–24 of 35
Cleared Jan 12, 2024
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
K233022
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d

About Product Code MSH - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code MSH since 1996, with 35 receiving FDA clearance (average review time: 97 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

MSH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →