# Xuchang Zhengde Environstar Medical Products Co., Ltd.

- Location (FDA's records): Xuchang, CN
- FDA decisions: 2 (2020–2022): 2 510(k) clearances
- Product codes: FYA (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gmax Industries, Inc.: 1 (https://510kreport.com/company/gmax-industries)

## Firms that cite its devices most
- Dukal Corp.: 1 (https://510kreport.com/company/dukal)
- Fugou County Shenxiang Manufacturing Co., Ltd.: 1 (https://510kreport.com/company/fugou-county-shenxiang-manufacturing)
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.: 1 (https://510kreport.com/company/bjzh-f-panther-medical-equipment)
- Winner Medical Co., Ltd.: 1 (https://510kreport.com/company/winner-medical)

## Its most-cited devices
- K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown (2020), cited by 5

## Recent decisions
- K213893: Comfort Gown, Safewear Gown (Dec 21, 2022)
- K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown (Apr 30, 2020)

Source page: https://510kreport.com/company/xuchang-zhengde-environstar-medical-products