Cleared Traditional

Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator

K141876 · Pasture Pharma Pte, Ltd. · General Hospital

Oct 2015

Decision

474d

Days

Class 2

Risk

About This 510(k) Submission

K141876 is an FDA 510(k) clearance for the Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator, a Respirator, Surgical (Class II — Special Controls, product code MSH), submitted by Pasture Pharma Pte, Ltd. (Murrieta, US). The FDA issued a Cleared decision on October 28, 2015, 474 days after receiving the submission on July 11, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K141876 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2014
Decision Date	October 28, 2015
Days to Decision	474 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).