Cleared Traditional

Protective Face Mask for Medical Use

K201537 · Shandong Shengquan New Material Co., Ltd. · General Hospital

Sep 2020

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K201537 is an FDA 510(k) clearance for the Protective Face Mask for Medical Use, 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 September 4, 2020, 88 days after receiving the submission on June 8, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K201537 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2020
Decision Date	September 04, 2020
Days to Decision	88 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF