# K210510: Disposable Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
- Decided: Aug 12, 2021 after 171 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 K020593 (2002). 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)
- K170762: Cardinal Health Non-Reinforced Surgical Gown, Cardinal Health200, LLC (2017) Summary page 4.

## Indications for use
The Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.

Source page: https://510kreport.com/device/K210510
Methodology: https://510kreport.com/methodology