# K220520: PM Excellence SEQUR 100 Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Pm Excellence, LLC
- Decided: Dec 15, 2022 after 295 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.
No later device cites it as a predicate yet.
0 of 5 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 4.

## Indications for use
The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials.

Source page: https://510kreport.com/device/K220520
Methodology: https://510kreport.com/methodology