Cleared Traditional

Surgical Masks

K212807 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
Dec 2021
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K212807 is an FDA 510(k) clearance for the Surgical Masks, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on December 3, 2021, 91 days after receiving the submission on September 3, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K212807 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2021
Decision Date December 03, 2021
Days to Decision 91 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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