# K221753: Kangbeier Child Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Xinxiang Kangbeier Medical Technology Co., Ltd.
- Decided: Dec 21, 2023 after 553 days
- Product code: OXZ (Pediatric/Child Facemask)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970835 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160100: Prestige Ameritech Pediatric/Child’s Face mask, Prestige Ameritech (2016) Summary page 4.

## Indications for use
The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

Source page: https://510kreport.com/device/K221753
Methodology: https://510kreport.com/methodology