Cleared Traditional

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

Jan 2024

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K233022 is an FDA 510(k) clearance for the 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, a Respirator, Surgical (Class II — Special Controls, product code MSH), submitted by Owens & Minor (O&M) Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on January 12, 2024, 112 days after receiving the submission on September 22, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K233022 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2023
Decision Date	January 12, 2024
Days to Decision	112 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	MSH — Respirator, Surgical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4040
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).