# K223411: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Probtain Medical Techology Co., Ltd.
- Decided: Jan 4, 2023 after 56 days
- Product code: FYC (Gown, Isolation, 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: 4 generations back to K952116 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210785: Disposable Surgical Gowns, Chongqing Litai Fashion Group Limited Company (2021) Summary page 4.

## Indications for use
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation 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 Isolation Gowns are single use, disposable medical devices, provided sterile.

Source page: https://510kreport.com/device/K223411
Methodology: https://510kreport.com/methodology