# K202615: Nordiwell Medical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Combat Protective Equipment Co., Ltd.
- Decided: Dec 31, 2020 after 113 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 K911334 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200847: Surgical Face Mask, Mexpo International, Inc. (2020) Summary page 4.

## Most influential descendants
- K210181: Nordiwell Surgical Face Mask (2021), 0 descendants of its own

## Indications for use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.

Source page: https://510kreport.com/device/K202615
Methodology: https://510kreport.com/methodology