# K203376: ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G

- Pathway: 510(k) (Traditional)
- Applicant: Medtecs (Taiwan) Corp.
- Decided: Mar 2, 2022 after 470 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: 5 generations back to K970835 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123115: Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/P, Acme Filter Mask, Inc. (2013) Summary page 4.

## Indications for use
ASTM Level 1/EN14683 Type IR 3-Ply disposable Surgical Mask, Model number: FM-140G are 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. The face masks are single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K203376
Methodology: https://510kreport.com/methodology