# K210147: Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

- Pathway: 510(k) (Traditional)
- Applicant: Unicoglobal, Inc.
- Decided: Dec 22, 2021 after 335 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)
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, 3M Healthcare (2019) Summary page 4.

## Most influential descendants
- K222266: Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) (2022), 0 descendants of its own

## Indications for use
The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are 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. The face masks are single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K210147
Methodology: https://510kreport.com/methodology