# K172445: RoyalGuard Surgical Gown, i600, Breathable

- Pathway: 510(k) (Traditional)
- Applicant: Gri Medical & Electrical Technology Co., Ltd.
- Decided: Dec 8, 2017 after 116 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 K080795 (2008). 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)
- K163191: ComfortGuard Surgical Gown, i600, Film Reinforced, Gri Medical & Electrical Technology Co., Ltd. (2017) Summary page 4.

## Indications for use
The RoyalGuard Surgical Gown, i600, Breathable is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The RoyalGuard Surgical Gown, i600, Breathable has been tested and is classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

Source page: https://510kreport.com/device/K172445
Methodology: https://510kreport.com/methodology