Cleared Traditional

iMask Disposable Surgical Face Mask

K201182 · Pac-Dent, Inc. · General Hospital
Feb 2021
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K201182 is an FDA 510(k) clearance for the iMask Disposable Surgical Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on February 19, 2021, 294 days after receiving the submission on May 1, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K201182 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2020
Decision Date February 19, 2021
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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