# K141085: WestTec Procedure Facemask;WestTec Surgical Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Westtec, LLC
- Decided: Mar 27, 2015 after 333 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: 5 generations back to K970835 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123787: Greencross Surgical Mask, Jingzhou Haixin Green Cross Medical Products Co.,L (2013) Summary page 4.

## Most influential descendants
- K210513: UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 (2021), 0 descendants of its own

## Indications for use
WestTec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.

Source page: https://510kreport.com/device/K141085
Methodology: https://510kreport.com/methodology