# K103150: Kimberly-Clark Child/Pediatric Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark
- Decided: Sep 23, 2011 after 332 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: 4 generations back to K970835 (1997). 9 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061716: Prestige Ameritech Face Mask, Prestige Ameritech (2006) Summary page 2.
- K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor, Crosstex International (2008) Summary page 2.
- K060776: Surgical Face Mask, Hong YA Non-Woven Products Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K113340: Kimberly-Clark Child's Facemask (2012), 5 descendants of its own
- K160100: Prestige Ameritech Pediatric/Child’s Face mask (2016), 4 descendants of its own
- K210321: Dukal Corporation Level 1 Pediatric Face Mask (2022), 1 descendant of its own
- K221753: Kangbeier Child Surgical Mask (2023), 0 descendants of its own
- K213427: PRIMED Pediatric Facemask (2022), 0 descendants of its own

## Indications for use
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

Source page: https://510kreport.com/device/K103150
Methodology: https://510kreport.com/methodology