# K121152: Surgical Gown, SMS

- Pathway: 510(k) (Abbreviated)
- Applicant: Jiangsu Guangda Medical Material, Co., Ltd.
- Decided: Dec 12, 2012 after 240 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: 3 generations back to K091097 (2009). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102652: Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns, Gri Medical & Electronic Technology Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K141467: Surgical Gown (2015), 1 descendant of its own
- K253003: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (2026), 0 descendants of its own
- K222456: High Protection Surgical Gown (2023), 0 descendants of its own
- K212812: Surgical Gown (2022), 0 descendants of its own

## Indications for use
Jiangsu Guangda's Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

Source page: https://510kreport.com/device/K121152
Methodology: https://510kreport.com/methodology