# K202706: Surgical Gown (Sterile), Surgical Gown (Non-sterile)

- Pathway: 510(k) (Traditional)
- Applicant: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
- Decided: Dec 31, 2020 after 106 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: 1 generation back to K192290 (2020). 1 ancestor in all.
5 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown, Xuchang Zhengde Environstar Medical Products Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K221559: Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 (2023), 0 descendants of its own
- K213844: Surgical Gown (2023), 0 descendants of its own
- K221637: Surgical Gown (Sterile); Surgical Gown (Non-sterile) (2022), 0 descendants of its own
- K211399: Sterile Level 3 Surgical Gown (2022), 0 descendants of its own
- K210355: Surgical Gown, Model: surgical gown-hp-3 (2021), 0 descendants of its own

## Indications for use
Surgical gowns are 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 surgical gowns met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K202706
Methodology: https://510kreport.com/methodology