# K222480: Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Nanhai Plus Medical Co, Ltd.
- Decided: Nov 14, 2022 after 89 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
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
The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are 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 material. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) meets the level 2 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.

Source page: https://510kreport.com/device/K222480
Methodology: https://510kreport.com/methodology