# K023755: Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with Shield

- Pathway: 510(k) (Traditional)
- Applicant: Winner Industries (Shenzhen) Co., Ltd.
- Decided: Jun 10, 2003 after 214 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012602: Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex, Crosstex Intl. (2002)
- K001892: White Knight Masks (21 Models, Various Colors with and Without Face Shields), White Knight Healthcare, Inc. (2001)

## Indications for use
Winner Medical facemask / shield are intended to be used 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 matter.

Source page: https://510kreport.com/device/K023755
Methodology: https://510kreport.com/methodology