# K230707: Skypro, Surgical Gown 6021

- Pathway: 510(k) (Traditional)
- Applicant: Skypro Medical Supplies Company
- Decided: Oct 12, 2023 after 212 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)
- K162442: ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500, Gri Medical & Electrical Technology Co., Ltd. (2016) Summary page 5.

## Indications for use
“Skypro, Surgical Gown 6021” are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.

Source page: https://510kreport.com/device/K230707
Methodology: https://510kreport.com/methodology