# K061716: Prestige Ameritech Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Prestige Ameritech
- Decided: Aug 14, 2006 after 56 days
- Product code: FXX (Mask, Surgical)
- 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: 3 generations back to K970835 (1997). 3 ancestors in all.
61 later devices descend from it; 5 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022256: Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green, Tucker & Associates (2004) Summary page 1.
- K060776: Surgical Face Mask, Hong YA Non-Woven Products Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K122717: Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask (2012), 45 descendants of its own
- K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) (2018), 35 descendants of its own
- K201479: DemeMASK (2020), 17 descendants of its own
- K153409: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) (2016), 7 descendants of its own
- K103150: Kimberly-Clark Child/Pediatric Face Mask (2011), 6 descendants of its own

## Indications for use
The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach

Source page: https://510kreport.com/device/K061716
Methodology: https://510kreport.com/methodology