OXZ — Pediatric/Child Facemask Class II
Classification Details
- Product Code
- OXZ
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221753 | xinxiang kangbeier medical technology co | Kangbeier Child Surgical Mask | December 21, 2023 |
| K213427 | primed medical products | PRIMED Pediatric Facemask | November 22, 2022 |
| K210321 | dukal corporation | Dukal Corporation Level 1 Pediatric Face Mask | March 29, 2022 |
| K201514 | shandong shengquan new material co | Child Face Mask | October 10, 2021 |
| K202831 | pac-dent | The iMask Child's Face Mask | August 26, 2021 |
| K190308 | amd medicom | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), | September 17, 2019 |
| K160100 | prestige ameritech | Prestige Ameritech Pediatric/Childs Face mask | October 7, 2016 |
| K113340 | kimberly-clark | KIMBERLY-CLARK CHILD'S FACEMASK | May 4, 2012 |
| K103150 | kimberly-clark | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | September 23, 2011 |