# Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

- Location (FDA's records): Weihai, CN
- FDA decisions: 6 (2012–2022): 6 510(k) clearances
- Product codes: FYA (2), LZA (1), KKX (1), FRG (1), FXX (1)
- 510(k) review time since 2016: median 88 days, against 170 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hangzhou Atek Medical & Textile Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-atek-medical-textile)
- Hebei Hongsen Plastics Technology Co, Ltd.: 1 (https://510kreport.com/company/hebei-hongsen-plastics-technology)
- Xiantao Rayxin Medical Products Co., Ltd.: 1 (https://510kreport.com/company/xiantao-rayxin-medical-products)
- Cardinal Health200, LLC: 1 (https://510kreport.com/company/cardinal-health200)
- Jiangsu Zhande Medical Supplies Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-zhande-medical-supplies)
- Shandong T&F Nonwoven Co., Ltd.: 1 (https://510kreport.com/company/shandong-t-f-nonwoven)

## Firms that cite its devices most
- Gmax Industries, Inc.: 1 (https://510kreport.com/company/gmax-industries)
- Guangzhou Fuzelong Hygiene Material Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-fuzelong-hygiene-material)

## Its most-cited devices
- K120192: Disposable Surgical Gowns (2012), cited by 1
- K214088: Disposable Surgical Gown (2022), cited by 1

## Recent decisions
- K214088: Disposable Surgical Gown (Apr 12, 2022)
- K220133: Sterilization Wraps (Mar 10, 2022)
- K213029: Nitrile Examination Gloves (Powder free, Blue) (Dec 14, 2021)
- K212807: Surgical Masks (Dec 3, 2021)
- K141324: Hongyu Disposable Surgical Drapes (Apr 14, 2015)
- K120192: Disposable Surgical Gowns (Oct 16, 2012)

Source page: https://510kreport.com/company/weihai-hongyu-nonwoven-fabric-products