# Grand Work Plastic Products Co., Ltd.

- Location (FDA's records): Zanhuang County, CN
- FDA decisions: 19 (2004–2023): 19 510(k) clearances
- Product codes: LYZ (11), LZA (6), KGO (2)
- 510(k) review time since 2016: median 104 days, against 111 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 16 (4 its own); citations of its devices by later devices: 9 (4 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
- Shijiazhuang Great Vision Plastic Products Co., LT: 3 (https://510kreport.com/company/shijiazhuang-great-vision-plastic-products-co-lt)
- Shijiazhuang Great Eagle Plastic Products Co., Ltd.: 2 (https://510kreport.com/company/shijiazhuang-great-eagle-plastic-products)
- Riverstone Resources Sdn Bhd: 1 (https://510kreport.com/company/riverstone-resources-sdn-bhd)
- Shanghai PM Plastics Enterise Co., Ltd.: 1 (https://510kreport.com/company/shanghai-pm-plastics-enterise)
- Hartalega NGC Sdn. Bhd.: 1 (https://510kreport.com/company/hartalega-ngc-sdn-bhd)
- Shijiazhuang Hongxiang Plastics Products Co., Ltd.: 1 (https://510kreport.com/company/shijiazhuang-hongxiang-plastics-products)
- Careplus (M) Sdn Bhd: 1 (https://510kreport.com/company/careplus-m-sdn-bhd)
- Hartalega Sdn Bhd: 1 (https://510kreport.com/company/hartalega-sdn-bhd)

## Firms that cite its devices most
- Bettercare Plastic Products Co., Ltd.: 2 (https://510kreport.com/company/bettercare-plastic-products)
- Shijiazhang Hongxiang Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/shijiazhang-hongxiang-plastic-products)
- Zibo Huiying Medical Products, Co., Ltd.: 1 (https://510kreport.com/company/zibo-huiying-medical-products)
- Ever Light Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/ever-light-plastic-products)

## Its most-cited devices
- K061562: Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color (2006), cited by 3
- K042830: Powder Free Vinyl Synthetic Examination Gloves (2004), cited by 2
- K051662: Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color) (2005), cited by 2
- K142409: Vinyl Co-Polymer Powder Free Examination Gloves (2014), cited by 1
- K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (2022), cited by 1

## Recent decisions
- K232444: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs (Dec 20, 2023)
- K232039: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Aug 9, 2023)
- K230217: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (May 13, 2023)
- K222892: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs (Dec 15, 2022)
- K213574: Nitrile Vinyl Blend Powder Free Examination Gloves (Black) (Jul 12, 2022)
- K220249: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) (May 26, 2022)
- K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (May 11, 2022)
- K220240: Vinyl Co-Polymer Powder-free Examination Gloves, Black (Mar 31, 2022)

Source page: https://510kreport.com/company/grand-work-plastic-products