Cleared Traditional

Child Face Mask

K201514 · Shandong Shengquan New Material Co., Ltd. · General Hospital

Oct 2021

Decision

489d

Days

Class 2

Risk

About This 510(k) Submission

K201514 is an FDA 510(k) clearance for the Child Face Mask, a Pediatric/child Facemask (Class II — Special Controls, product code OXZ), submitted by Shandong Shengquan New Material Co., Ltd. (Jinan, CN). The FDA issued a Cleared decision on October 10, 2021, 489 days after receiving the submission on June 8, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K201514 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2020
Decision Date	October 10, 2021
Days to Decision	489 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.