# K211497: Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Honeywell Safety Products
- Decided: Jul 28, 2021 after 75 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: 8 generations back to K874608 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210445: Nordiwell Surprotect Face Mask, Changzhou Combat Protective Equipment Co., Ltd. (2021). Cleared while this submission was under review Summary page 4.

## Indications for use
The Honeywell Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. 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, provided non-sterile.

Source page: https://510kreport.com/device/K211497
Methodology: https://510kreport.com/methodology