Cleared Traditional

Surgical Face Mask

K210518 · Shandong Haidike Medical Products Co., Ltd. · General Hospital
Jun 2021
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K210518 is an FDA 510(k) clearance for the Surgical Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Shandong Haidike Medical Products Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on June 14, 2021, 111 days after receiving the submission on February 23, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K210518 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2021
Decision Date June 14, 2021
Days to Decision 111 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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