# K160100: Prestige Ameritech Pediatric/Child’s Face mask

- Pathway: 510(k) (Traditional)
- Applicant: Prestige Ameritech
- Decided: Oct 7, 2016 after 262 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: 6 generations back to K970835 (1997). 11 ancestors in all.
4 later devices descend from it; 3 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)
- K113340: Kimberly-Clark Child's Facemask, Kimberly-Clark (2012) Summary page 5.

## Most influential descendants
- 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 Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the patient/child. The Pediatric/Child Facemask is a single use, disposable device, provided non-sterile. The Pediatric/Child Facemask is intended to be worn by the patient (ages 4-12) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur.

Source page: https://510kreport.com/device/K160100
Methodology: https://510kreport.com/methodology