Cleared Abbreviated

DEFEND Ear-loop Face Masks

K201127 · Young Dental Manufacturing Co. 1, LLC · General Hospital
Apr 2021
Decision
351d
Days
Class 2
Risk

About This 510(k) Submission

K201127 is an FDA 510(k) clearance for the DEFEND Ear-loop Face Masks, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on April 14, 2021, 351 days after receiving the submission on April 28, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K201127 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2020
Decision Date April 14, 2021
Days to Decision 351 days
Submission Type Abbreviated
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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