# K102713: Tiger Flat Surgical Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Tiger Medical Products, Ltd.
- Decided: Jan 25, 2011 after 127 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022256: Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green, Tucker & Associates (2004) Summary page 1.
- K061716: Prestige Ameritech Face Mask, Prestige Ameritech (2006) Summary page 1.

## Indications for use
The Tiger SFMOO01 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Source page: https://510kreport.com/device/K102713
Methodology: https://510kreport.com/methodology