# K163191: ComfortGuard Surgical Gown, i600, Film Reinforced

- Pathway: 510(k) (Traditional)
- Applicant: Gri Medical & Electrical Technology Co., Ltd.
- Decided: Feb 27, 2017 after 105 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: 1 generation back to K080795 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080795: Ultra Surgical Gown & Fluid Barrier Surgical Gown, Kimberly-Clark Corp. (2008) Summary page 4.

## Most influential descendants
- K172445: RoyalGuard Surgical Gown, i600, Breathable (2017), 0 descendants of its own

## Indications for use
The ComfortGuard Surgical Gown, 1600, Film Reinforced 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 ComfortGuard Surgical Gown, 1600, Film Reinforced 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/K163191
Methodology: https://510kreport.com/methodology