K221753 is an FDA 510(k) clearance for the Kangbeier Child Surgical Mask. This device is classified as a Pediatric/child Facemask (Class II - Special Controls, product code OXZ).
Submitted by Xinxiang Kangbeier Medical Technology Co., Ltd. (Changyuan, CN). The FDA issued a Cleared decision on December 21, 2023, 553 days after receiving the submission on June 16, 2022.
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 | K221753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2022 |
| Decision Date | December 21, 2023 |
| Days to Decision | 553 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |