# K060776: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Hong YA Non-Woven Products Co., Ltd.
- Decided: May 25, 2006 after 64 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: 2 generations back to K970835 (1997). 2 ancestors in all.
73 later devices descend from it; 4 cite it directly.
0 of 76 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 2.

## Most influential descendants
- K061716: Prestige Ameritech Face Mask (2006), 61 descendants of its own
- 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

## Indications for use
Surgical Face Mask is device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K060776
Methodology: https://510kreport.com/methodology