# K221717: Disposable Surgical Gown UM-148

- Pathway: 510(k) (Traditional)
- Applicant: Unimax Medical Products Co., Ltd.
- Decided: Sep 20, 2022 after 99 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: 3 generations back to K020593 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212591: Disposable Surgical Gown, Suzhou Janee Medical Technology Co., Ltd. (2022) Summary page 4.

## Indications for use
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

Source page: https://510kreport.com/device/K221717
Methodology: https://510kreport.com/methodology