Cleared Traditional

K171116 - 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S (FDA 510(k) Clearance)

K171116 · 3M Healthcare · General Hospital
Aug 2017
Decision
118d
Days
Class 2
Risk

K171116 is an FDA 510(k) clearance for the 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S. This device is classified as a Respirator, Surgical (Class II - Special Controls, product code MSH).

Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on August 10, 2017, 118 days after receiving the submission on April 14, 2017.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040. 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)..

Submission Details

510(k) Number K171116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2017
Decision Date August 10, 2017
Days to Decision 118 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).