# K131879: KC 300 Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Dec 20, 2013 after 179 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K874608 (1987). 7 ancestors in all.
185 later devices descend from it; 3 cite it directly.
0 of 193 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 2.
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model, Kimberly-Clark (2011) Summary page 2.

## Most influential descendants
- 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
- K182515: Surgical Face Mask (2019), 50 descendants of its own
- K182514: Surgical Face Mask (2019), 29 descendants of its own
- K200923: Single-use Surgical Mask (2020), 16 descendants of its own

## Recalls of this device
- Jan 3, 2023 · Class III · Z-1059-2023: Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

## Indications for use
The Kimberly-Clark KC300 Face Mask 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. Product code 47297, KC080 FLUIDSHIELD* Procedure Mask wit SO SOFT* Lining Product code 47298, KC300 FLIISILDo Fog-Free Procedure Mask with SO SOFT* Lining Product code 48297 KC300 FLUIDSHIELD$ Surgical Mask with SO SOFT* Lining

Source page: https://510kreport.com/device/K131879
Methodology: https://510kreport.com/methodology