# K063043: Surgical Face Mask, Type: Tie-on, Ear-Loop

- Pathway: 510(k) (Traditional)
- Applicant: Modern Healthcare Corp.
- Decided: Mar 21, 2007 after 169 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 K970835 (1997). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060776: Surgical Face Mask, Hong YA Non-Woven Products Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K123115: Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/P (2013), 2 descendants of its own
- K201549: Motex Anti-Fog Surgical Face Mask (2020), 1 descendant of its own
- K203376: ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G (2022), 0 descendants of its own
- K212863: Surgical Face Mask (2022), 0 descendants of its own
- K202126: Disposable Surgical Mask (2021), 0 descendants of its own

## Indications for use
The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material. This Surgical Face Mask is non-sterilized and disposable for use.

Source page: https://510kreport.com/device/K063043
Methodology: https://510kreport.com/methodology