# K955557: Fluid Reisistant Eyeshield Mask

- Pathway: 510(k) (Traditional)
- Applicant: American Threshold Healthcare
- Decided: Apr 25, 1996 after 142 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: 1 generation back to K874608 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874608: Tecnol Fluid Shield Surgical Mask, Tecnol New Jersey Wound Care, Inc. (1987) Summary page 1.
- K910110: Triple Layer Fluid-Resistant Molded Face Mask, 3M Company (1991) Summary page 1.

## Indications for use
This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

Source page: https://510kreport.com/device/K955557
Methodology: https://510kreport.com/methodology