# K093169: Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown (Sterile) (Non Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: A Plus International, Inc.
- Decided: Nov 12, 2009 after 36 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
SurgiPlus Surgical Gowns are single use article of surgical apparel intended to be worn by operating room personnel during surgical and other medical procedures to protect both the medical personnel and patients from transfer of blood, body fluids, and particulate materials.

Source page: https://510kreport.com/device/K093169
Methodology: https://510kreport.com/methodology