# K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks

- Pathway: 510(k) (Abbreviated)
- Applicant: Kimberly-Clark Corp.
- Decided: Apr 29, 2011 after 73 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: 3 generations back to K874608 (1987). 5 ancestors in all.
289 later devices descend from it; 19 cite it directly.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor, Crosstex International (2008) Summary page 2.

## Most influential descendants
- 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
- K160269: Surgical Face Masks (Ear loops and Tie-on) (2016), 60 descendants of its own

## Indications for use
The Kimberly-Clark KC100 Face Mask(s) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Kimberly-Clark KC100 face mask(s) is a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K110455
Methodology: https://510kreport.com/methodology