# Sunmax Enterprise Shanghai Co., Ltd.

- Location (FDA's records): Great Neck, NY
- FDA decisions: 5 (1996–2009): 5 510(k) clearances
- Product codes: LZA (3), LYZ (2)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 13 (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
- Shanghai China Star Corp: 1 (https://510kreport.com/company/shanghai-china-star)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Honyee Enterprise Co.: 1 (https://510kreport.com/company/honyee-enterprise)
- Cheer & Merit Co., Ltd.: 1 (https://510kreport.com/company/cheer-merit)

## Firms that cite its devices most
- Shijiazhuang Hongxiang Plastics Products Co., Ltd.: 2 (https://510kreport.com/company/shijiazhuang-hongxiang-plastics-products)
- Shijiazhuang Great Eagle Plastic Products Co., Ltd.: 2 (https://510kreport.com/company/shijiazhuang-great-eagle-plastic-products)
- Shanghai Super Gloves Co., Ltd.: 2 (https://510kreport.com/company/shanghai-super-gloves)
- Shijiazhuang Great Vision Plastic Products Co., LT: 2 (https://510kreport.com/company/shijiazhuang-great-vision-plastic-products-co-lt)
- Shijiazhuang Dilly Plastics Products Co., Ltd.: 2 (https://510kreport.com/company/shijiazhuang-dilly-plastics-products)
- Zibo Yinghao Medical Products Co., Ltd.: 1 (https://510kreport.com/company/zibo-yinghao-medical-products)
- Sunmax Vietnam Co., Ltd.: 1 (https://510kreport.com/company/sunmax-vietnam)
- Tangshan Jiteng Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/tangshan-jiteng-plastic-products)

## Its most-cited devices
- K960746: Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves (1996), cited by 5
- K964964: Powder-Free Vinyl Patient Examination Gloves (1997), cited by 5
- K090336: Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs (2009), cited by 3

## Recent decisions
- K090336: Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs (Jul 1, 2009)
- K011765: Sunmax Blue Nitrile Powder-Free Examination Glove (Aug 16, 2001)
- K011717: Sunmax Blue Nitrile Powdered Examination Gloves (Aug 14, 2001)
- K964964: Powder-Free Vinyl Patient Examination Gloves (Feb 7, 1997)
- K960746: Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves (Jun 27, 1996)

Source page: https://510kreport.com/company/sunmax-enterprise-shanghai
