# Zhonghong Pulin Medical Products Co., Ltd.

- Location (FDA's records): Tangshan, CN
- FDA decisions: 5 (2016–2023): 5 510(k) clearances
- Product codes: LZA (4), LYZ (1)
- 510(k) review time since 2016: median 170 days, against 92 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (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
- Ever Global (Vietnam) Enterprise Corporation: 1 (https://510kreport.com/company/ever-global-vietnam-enterprise)
- Tangshan Zhonghong Pulin Plastic Co.,Ltd: 1 (https://510kreport.com/company/tangshan-zhonghong-pulin-plastic)
- Kossan International Sdn Bhd: 1 (https://510kreport.com/company/kossan-international-sdn-bhd)

## Recent decisions
- K231029: Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl (Oct 30, 2023)
- K230662: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs (Oct 26, 2023)
- K210460: NitriTec Vinyl Glove Powder Free Blue (May 17, 2021)
- K171873: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs (Nov 15, 2017)
- K152712: Nitrile Powder Free Patient Examination Gloves, Blue Color (Mar 9, 2016)

Source page: https://510kreport.com/company/zhonghong-pulin-medical-products
