Cleared Abbreviated

Surgical Face Masks (Ear loops and Tie-on)

K160269 · San-M Package Co., Ltd. · General Hospital

Sep 2016

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K160269 is an FDA 510(k) clearance for the Surgical Face Masks (Ear loops and Tie-on), a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by San-M Package Co., Ltd. (Shimada-City, JP). The FDA issued a Cleared decision on September 6, 2016, 217 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	K160269 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2016
Decision Date	September 06, 2016
Days to Decision	217 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Summary PDF