# K103303: Crosstex Surgical Earloop Mask- White, Crosstex Surgical Earloop NO Fog Mask-White, NO Fog Mask with Splash Visor-White

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex International, Inc.
- Decided: Dec 23, 2010 after 44 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 Ultra Fluid Resistant No Fog Earloop Face Mask: named in the summary without a submission number

## Indications for use
The following Crosstex® 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. * Crosstex® Surgical Earloop Mask - White * Crosstex® Surgical Earloop No Fog Mask - White * Crosstex® Surgical Earloop No Fog Mask with Splash Visor - White

Source page: https://510kreport.com/device/K103303
Methodology: https://510kreport.com/methodology