Cleared Traditional

Dukal Corporation Level 1 Pediatric Face Mask

K210321 · Dukal Corporation · General Hospital
Mar 2022
Decision
418d
Days
Class 2
Risk

About This 510(k) Submission

K210321 is an FDA 510(k) clearance for the Dukal Corporation Level 1 Pediatric Face Mask, a Pediatric/child Facemask (Class II — Special Controls, product code OXZ), submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on March 29, 2022, 418 days after receiving the submission on February 4, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K210321 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2021
Decision Date March 29, 2022
Days to Decision 418 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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.

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