# K910110: Triple Layer Fluid-Resistant Molded Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Mar 20, 1991 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
No predicates in its family tree.
331 later devices descend from it; 2 cite it directly.
0 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955556: Fluid Resistant Mask (1996), 329 descendants of its own
- K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor (2008), 299 descendants of its own
- 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

Source page: https://510kreport.com/device/K910110
Methodology: https://510kreport.com/methodology