Cleared Traditional

Disposable Medical Face Mask (DF3-001)

K222697 · Wellmed Dental Medical Supply Co., Ltd. · General Hospital

Nov 2022

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K222697 is an FDA 510(k) clearance for the Disposable Medical Face Mask (DF3-001), a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Wellmed Dental Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 4, 2022, 58 days after receiving the submission on September 7, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K222697 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2022
Decision Date	November 04, 2022
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF