# K162442: ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

- Pathway: 510(k) (Traditional)
- Applicant: Gri Medical & Electrical Technology Co., Ltd.
- Decided: Dec 12, 2016 after 103 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 5.

## Most influential descendants
- K230707: Skypro, Surgical Gown 6021 (2023), 0 descendants of its own

## Indications for use
ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 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/K162442
Methodology: https://510kreport.com/methodology