# K123115: Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/P

- Pathway: 510(k) (Traditional)
- Applicant: Acme Filter Mask, Inc.
- Decided: May 20, 2013 after 229 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 K970835 (1997). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063043: Surgical Face Mask, Type: Tie-on, Ear-Loop, Modern Healthcare Corp. (2007) Summary page 1.

## Most influential descendants
- K203376: ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G (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 (Blue, hite, and Green) 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 froms transfer of bacteria, body fluid.and particulate material. This Surgical Face Mask iv win-sterilized and disposable.

Source page: https://510kreport.com/device/K123115
Methodology: https://510kreport.com/methodology