# K221559: Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Stringking
- Decided: Feb 23, 2023 after 268 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 K192290 (2020). 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)
- K202706: Surgical Gown (Sterile), Surgical Gown (Non-sterile), B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (2020) Summary page 4.

## Indications for use
The StringKing Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

Source page: https://510kreport.com/device/K221559
Methodology: https://510kreport.com/methodology