# K212698: Plus Medical Isolation Gown Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Nanhai Plus Medical Co, Ltd.
- Decided: Mar 2, 2022 after 189 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Plus Medical Isolation Gowns Level 3 are intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. The gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. The gown is a full-back design and is provided non-sterile, single use medical device.

Source page: https://510kreport.com/device/K212698
Methodology: https://510kreport.com/methodology