Cleared Traditional

Surgical Mask

K213358 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · General Hospital
Mar 2022
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K213358 is an FDA 510(k) clearance for the Surgical Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 4, 2022, 143 days after receiving the submission on October 12, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K213358 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2021
Decision Date March 04, 2022
Days to Decision 143 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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