Cleared Traditional

Surgical Face Mask

K212610 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
Jan 2022
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K212610 is an FDA 510(k) clearance for the Surgical Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN). The FDA issued a Cleared decision on January 26, 2022, 162 days after receiving the submission on August 17, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K212610 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2021
Decision Date January 26, 2022
Days to Decision 162 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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