# K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Xuchang Zhengde Environstar Medical Products Co., Ltd.
- Decided: Apr 30, 2020 after 251 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.
13 later devices descend from it; 5 cite it directly.
0 of 14 devices 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.

## Most influential descendants
- K202706: Surgical Gown (Sterile), Surgical Gown (Non-sterile) (2020), 5 descendants of its own
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants 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
- K221559: Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 (2023), 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, SMS Standard Surgical Gown and SMS Surgical Gown with Reinforcement met the requirements for Level 3 classification; BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification.

Source page: https://510kreport.com/device/K192290
Methodology: https://510kreport.com/methodology