# K123787: Greencross Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Jingzhou Haixin Green Cross Medical Products Co.,L
- Decided: Jul 17, 2013 after 219 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.
2 later devices descend 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)
- K101000: Wellmien Surgical Mask, Wellmien (Suzhou) Import & Export Trading Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K141085: WestTec Procedure Facemask;WestTec Surgical Facemask (2015), 1 descendant of its own
- K210513: UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 (2021), 0 descendants of its own

## Indications for use
The GreenCross Surgical Masks are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

Source page: https://510kreport.com/device/K123787
Methodology: https://510kreport.com/methodology