# K201514: Child Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Shengquan New Material Co., Ltd.
- Decided: Oct 10, 2021 after 489 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Children Face Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision.

Source page: https://510kreport.com/device/K201514
Methodology: https://510kreport.com/methodology