Cleared Traditional

Disposable Medical Face Masks

K202719 · Jiangxi Sanxin Medtec Co., Ltd. · General Hospital

Jan 2021

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K202719 is an FDA 510(k) clearance for the Disposable Medical Face Masks, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Jiangxi Sanxin Medtec Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on January 4, 2021, 109 days after receiving the submission on September 17, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K202719 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2020
Decision Date	January 04, 2021
Days to Decision	109 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF