# K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model

- Pathway: 510(k) (Abbreviated)
- Applicant: Kimberly-Clark
- Decided: Oct 20, 2011 after 154 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: 4 generations back to K874608 (1987). 6 ancestors in all.
262 later devices descend from it; 9 cite it directly.
0 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks, Kimberly-Clark Corp. (2011) Summary page 1.

## Most influential descendants
- 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
- K182515: Surgical Face Mask (2019), 50 descendants of its own

## Indications for use
The Kimberly-Clark, K0200 and KC300 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, KC200 and KC300 face mask(s) is a single use, disposable device(s), provided non-sterile. KC200 Procedure Mask KC200 Procedure Mask, fog free with visor KC200 Surgical Mask, fog free KC200 Surgical Mask, fog free with visor KC300 Procedure Mask, Fluidshieldt , fog free KC300 Procedure Mask, Fluidshieldt , fog free with visor KC300 Surgical Mask, Fluidshield, fog free KC300 Surgical Mask, Fluidshield*, fog free with visor

Source page: https://510kreport.com/device/K111402
Methodology: https://510kreport.com/methodology