Cleared Traditional

Disposable Surgical Mask

K202954 · Xiamen Probtain Medical Techology Co., Ltd. · General Hospital
Jul 2021
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K202954 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 July 2, 2021, 275 days after receiving the submission on September 30, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K202954 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2020
Decision Date July 02, 2021
Days to Decision 275 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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