Cleared Traditional

3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

K121069 · 3M Company · General Hospital
Feb 2013
Decision
308d
Days
Class 2
Risk

About This 510(k) Submission

K121069 is an FDA 510(k) clearance for the 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, a Respirator, Surgical (Class II — Special Controls, product code MSH), submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on February 11, 2013, 308 days after receiving the submission on April 9, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K121069 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2012
Decision Date February 11, 2013
Days to Decision 308 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).

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