Cleared Traditional

Medical Face Mask

K201629 · Shandong Shengquan New Material Co., Ltd. · General Hospital

Dec 2020

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K201629 is an FDA 510(k) clearance for the Medical Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Shandong Shengquan New Material Co., Ltd. (Jinan, CN). The FDA issued a Cleared decision on December 14, 2020, 181 days after receiving the submission on June 16, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K201629 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2020
Decision Date	December 14, 2020
Days to Decision	181 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF