# K122717: Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Tiger Medical Products, Ltd.
- Decided: Dec 21, 2012 after 107 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: 4 generations back to K970835 (1997). 4 ancestors in all.
45 later devices descend from it; 3 cite it directly.
0 of 50 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 1.

## Most influential descendants
- 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
- K202843: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) (2021), 5 descendants of its own
- K210030: Medical Surgical Mask (2021), 4 descendants of its own

## Indications for use
The following surgical masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. -face mask (earloop) -face mask (tie-on) -surgical mask (earloop) -surgical mask (tie-on) -surgical face mask (earloap) -surgical face mask (tie-on)

Source page: https://510kreport.com/device/K122717
Methodology: https://510kreport.com/methodology