Cleared Traditional

K203425 - Surgical Mask
(FDA 510(k) Clearance)

K203425 · Bdc Dental Corporation , Ltd. · General Hospital

Mar 2021

Decision

105d

Days

Class 2

Risk

K203425 is an FDA 510(k) clearance for the Surgical Mask. This device is classified as a Mask, Surgical (Class II — Special Controls, product code FXX).

Submitted by Bdc Dental Corporation , Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 5, 2021, 105 days after receiving the submission on November 20, 2020.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K203425 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2020
Decision Date	March 05, 2021
Days to Decision	105 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF