# K113340: Kimberly-Clark Child's Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark
- Decided: May 4, 2012 after 172 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: 5 generations back to K970835 (1997). 10 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K103150: Kimberly-Clark Child/Pediatric Face Mask, Kimberly-Clark (2011) Summary page 1.

## Most influential descendants
- 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
- K190308: Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) (2019), 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 4-12) 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/K113340
Methodology: https://510kreport.com/methodology