# Hebei Titans Hongsen Medical Technology Co., Ltd.

- Location (FDA's records): Xingtai, CN
- FDA decisions: 7 (2018–2024): 7 510(k) clearances
- Product codes: LZA (2), LYZ (2), LYY (1), LZC (1), FXX (1)
- 510(k) review time since 2016: median 85 days, against 92 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 4 (1 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
- Humanwell Healthcare Group Medical Supplies Co., Ltd.: 1 (https://510kreport.com/company/humanwell-healthcare-group-medical-supplies)
- Raxwell Industrial, LLC: 1 (https://510kreport.com/company/raxwell-industrial)
- Hebei Hongtai Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/hebei-hongtai-plastic-products)
- Huifu Trading Co., Ltd.: 1 (https://510kreport.com/company/huifu-trading)
- Bestsafe Glove Co., Ltd.: 1 (https://510kreport.com/company/bestsafe-glove)
- Hebei Hongsen Plastics Technology Co, Ltd.: 1 (https://510kreport.com/company/hebei-hongsen-plastics-technology)
- Improve Medical (Hunan) Co., Ltd.: 1 (https://510kreport.com/company/improve-medical-hunan)

## Firms that cite its devices most
- Shanghai Hua EN Industrial Co, Ltd.: 1 (https://510kreport.com/company/shanghai-hua-en-industrial)
- Jiangxi Hongda Medical Equipment Group, Ltd.: 1 (https://510kreport.com/company/jiangxi-hongda-medical-equipment-group)
- Vista Industries,, LLC: 1 (https://510kreport.com/company/vista-industries)

## Its most-cited devices
- K182043: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (2018), cited by 2
- K240361: Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) (2024), cited by 1
- K212097: Disposable medical surgical mask (2021), cited by 1

## Recent decisions
- K240361: Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) (Apr 4, 2024)
- K223895: Disposable Medical Nitrile Examination Gloves (Mar 23, 2023)
- K221374: Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (Oct 26, 2022)
- K212097: Disposable medical surgical mask (Aug 18, 2021)
- K211229: Vinyl compound examination gloves (Jul 29, 2021)
- K182043: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (Sep 21, 2018)
- K181130: Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Aug 10, 2018)

Source page: https://510kreport.com/company/hebei-titans-hongsen-medical-technology