# K210445: Nordiwell Surprotect Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Combat Protective Equipment Co., Ltd.
- Decided: Jun 29, 2021 after 133 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: 7 generations back to K874608 (1987). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180874: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield, 3M Healthcare (2018) Summary page 4.

## Most influential descendants
- K211497: Surgical Mask (2021), 0 descendants of its own

## Indications for use
The Nordiwell Medical Face Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matters. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.

Source page: https://510kreport.com/device/K210445
Methodology: https://510kreport.com/methodology