Cleared Traditional

The iMask Child's Face Mask

K202831 · Pac-Dent, Inc. · General Hospital

Aug 2021

Decision

335d

Days

Class 2

Risk

About This 510(k) Submission

K202831 is an FDA 510(k) clearance for the The iMask Child's Face Mask, a Pediatric/child Facemask (Class II — Special Controls, product code OXZ), submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on August 26, 2021, 335 days after receiving the submission on September 25, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K202831 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2020
Decision Date	August 26, 2021
Days to Decision	335 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	OXZ — Pediatric/child Facemask
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4040
Definition	A Pediatric/child Facemask Is Intended To Be Worn By The Patient/child To Provide Protection For The Respiratory Tract. It Is A Single Use, Disposable Device That Is Provided Non-sterile. The Facemask Is Recommended For Use In A Healthcare Setting With Appropriate Adult Supervision.