# K100846: Imc Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection
- Decided: Aug 16, 2010 after 144 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). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991559: Medline Prohibit Series Surgical Mask with Fluid Shield, Medline Industries, Inc. (1999) Summary page 1.
- K012602: Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex, Crosstex Intl. (2002) Summary page 1.

## Most influential descendants
- K212375: Disposable Medical Surgical Mask (2022), 0 descendants of its own
- K202954: Disposable Surgical Mask (2021), 0 descendants of its own
- K210429: Disposable Surgical Face Mask (2021), 0 descendants of its own

## Indications for use
This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K100846
Methodology: https://510kreport.com/methodology