# K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex International
- Decided: Oct 16, 2008 after 69 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: 2 generations back to K874608 (1987). 4 ancestors in all.
299 later devices descend from it; 4 cite it directly.
0 of 304 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801036: Surgical Mask, American Threshold Industries, Inc. (1980) Summary page 1.
- K955556: Fluid Resistant Mask, American Threshold Healthcare (1996) Summary page 1.

## Most influential descendants
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks (2011), 289 descendants of its own
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model (2011), 262 descendants of its own
- K131879: KC 300 Surgical Mask (2013), 185 descendants of its own
- K133070: SURGICAL FACE MASK (Ear Loops and Tie-on) (2015), 170 descendants of its own
- K153496: Disposable Surgical Face Mask (2016), 158 descendants of its own

## 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® Isolite® Earloop Face Masks - Blue, Pink * Crosstex® Isofluid® Earloop Face Masks - Blue, Pink, White, Green * Crosstex® Isofluid FogFree® Earloop Face Masks - Blue, Peach * Crosstex® Isofluid FogFree® Face Masks with Splash Visor - Blue, Peach * Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow * Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks - Blue * Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor - Blue

Source page: https://510kreport.com/device/K082258
Methodology: https://510kreport.com/methodology