Cleared Abbreviated

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

K160271 · San-M Package Co., Ltd. · General Hospital

Jul 2016

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K160271 is an FDA 510(k) clearance for the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, a Respirator, Surgical (Class II — Special Controls, product code MSH), submitted by San-M Package Co., Ltd. (Shimada-City, JP). The FDA issued a Cleared decision on July 15, 2016, 164 days after receiving the submission on February 2, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K160271 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2016
Decision Date	July 15, 2016
Days to Decision	164 days
Submission Type	Abbreviated
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).