# K012602: Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex Intl.
- Decided: Jan 22, 2002 after 162 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.
28 later devices descend from it; 5 cite it directly.
0 of 33 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 2.

## Most influential descendants
- K040333: Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without Visors, Ties and Earloops (2004), 21 descendants of its own
- K051291: Non-Sterile Surgical Mask (2005), 20 descendants of its own
- K092580: Tidi Facemask (2010), 9 descendants of its own
- K061864: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560 (2006), 6 descendants of its own
- K111559: Surgical Masks (2011), 4 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/K012602
Methodology: https://510kreport.com/methodology