# Shandong Xingyu Gloves Co., Ltd.

- Location (FDA's records): Gaomi, CN
- FDA decisions: 4 (2017–2024): 4 510(k) clearances
- Product codes: LZA (3), FXX (1)
- 510(k) review time since 2016: median 59 days, against 119 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 6 (0 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
- Tangshan Zhonghong Pulin Plastic Co.,Ltd: 1 (https://510kreport.com/company/tangshan-zhonghong-pulin-plastic)
- Semperit Investments Asia Pte, Ltd.: 1 (https://510kreport.com/company/semperit-investments-asia)
- Jiangsu Dongling Plastic & Rubber Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-dongling-plastic-rubber)
- Macheng Thimble Technology Investment Co., Ltd.: 1 (https://510kreport.com/company/macheng-thimble-technology-investment)

## Firms that cite its devices most
- Henan Chaoya Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/henan-chaoya-medical-equipment)
- Safeskin Retailing (Hk) Limited: 1 (https://510kreport.com/company/safeskin-retailing-hk)
- Social Medical Supply, LLC: 1 (https://510kreport.com/company/social-medical-supply)
- Xingyu Medical Tech Co., Ltd.: 1 (https://510kreport.com/company/xingyu-medical-tech)
- Hong Seng Gloves Sdn Bhd: 1 (https://510kreport.com/company/hong-seng-gloves-sdn-bhd)
- Onetexx Sdn Bhd: 1 (https://510kreport.com/company/onetexx-sdn-bhd)

## Its most-cited devices
- K171615: Xingyu Nitrile Powder Free Patient Examination Gloves, White color (2017), cited by 3
- K221272: Medical Face Mask (2022), cited by 2
- K171616: Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color (2017), cited by 1

## Recent decisions
- K233990: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) (Apr 1, 2024)
- K221272: Medical Face Mask (Jun 28, 2022)
- K171615: Xingyu Nitrile Powder Free Patient Examination Gloves, White color (Jul 31, 2017)
- K171616: Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color (Jul 20, 2017)

Source page: https://510kreport.com/company/shandong-xingyu-gloves