Cleared Traditional

Surgical Masks

K203524 · Bain Medical Equipment (Guangzhou) Co., Ltd. · General Hospital
Feb 2021
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K203524 is an FDA 510(k) clearance for the Surgical Masks, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 25, 2021, 86 days after receiving the submission on December 1, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K203524 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2020
Decision Date February 25, 2021
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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