Cleared Traditional

Ear-Friendly Mask

K211105 · Ray Co., Ltd. · General Hospital
May 2021
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K211105 is an FDA 510(k) clearance for the Ear-Friendly Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Ray Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on May 17, 2021, 34 days after receiving the submission on April 13, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K211105 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2021
Decision Date May 17, 2021
Days to Decision 34 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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