# K062479: Joykey Surgical Gowns (Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Joykey Industryial, Ltd.
- Decided: Mar 14, 2007 after 202 days
- Product code: FYA (Gown, 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: 2 generations back to K964142 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012186: Master & Frank Surgical Gowns (Sterile), Master & Frank Ent. Co., Ltd. (2001) Summary page 1.

## Indications for use
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.

Source page: https://510kreport.com/device/K062479
Methodology: https://510kreport.com/methodology