# K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.
- Decided: Jul 2, 2021 after 56 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: 5 generations back to K964142 (1997). 8 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001), Gmax Industries, Inc. (2018) Summary page 6.

## Most influential descendants
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K212861: Surgical Gown, Reinforced Surgical Gown (2021), 2 descendants of its own
- K231510: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) (2023), 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
- K233571: GCI Surgical Gown (2024), 0 descendants of its own

## Indications for use
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K211422
Methodology: https://510kreport.com/methodology