# K101000: Wellmien Surgical Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Wellmien (Suzhou) Import & Export Trading Co., Ltd.
- Decided: Aug 9, 2010 after 119 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.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060776: Surgical Face Mask, Hong YA Non-Woven Products Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K123787: Greencross Surgical Mask (2013), 2 descendants of its own
- K141085: WestTec Procedure Facemask;WestTec Surgical Facemask (2015), 1 descendant of its own
- K220520: PM Excellence SEQUR 100 Surgical Face Mask (2022), 0 descendants 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 Wellmien Surgical Masks (for single use only) 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/K101000
Methodology: https://510kreport.com/methodology