# K111343: Crosstex Isofluid Plus Surgical Earloop Mask-Blue, Crosstex Isofluid Plus Fogfree Surgical Earloop Face Mask-Blue, Cross

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex International, Inc.
- Decided: Oct 6, 2011 after 146 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Crosstex Isofluid FogFree Earloop Face Mask: named in the summary without a submission number

## Indications for use
The following Crosstex® Isofluid Plus Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. (non-sterile) * Crosstex® Isofluid Plus Surgical Earloop Face Mask - Blue * Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask - Blue * Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask with Splash Visor - Blue

Source page: https://510kreport.com/device/K111343
Methodology: https://510kreport.com/methodology