Cleared Traditional

Disposable Surgical Mask

K201893 · Xiamen Probtain Medical Techology Co., Ltd. · General Hospital
Dec 2020
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K201893 is an FDA 510(k) clearance for the Disposable Surgical Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Xiamen Probtain Medical Techology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on December 9, 2020, 154 days after receiving the submission on July 8, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K201893 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2020
Decision Date December 09, 2020
Days to Decision 154 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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