K201514 is an FDA 510(k) clearance for the Child Face Mask. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4040. 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..
| 510(k) Number | K201514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |