Hebei Titans Hongsen Medical Technology Co., Ltd.
Registered establishment in Xingtai, Hebei, China. 3 device types, 7 clearances.
Hebei Titans Hongsen Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Vinyl Patient Examination Glove and 1 other device type. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010582952 |
| FEI number | 3010582952 |
| Establishment type | Manufacturer |
Location
| City | Xingtai |
|---|---|
| Province | Hebei |
| Address | Eastern Industrial Zone |
| Postal code | 051800 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Medical Glove, Specialty | Class 1 | Powder Free Blue Nitrile Examination Gloves, Tested for Use With Chemotherapy Drugs, Powder Free Blue Nitrile Gloves, Tested For Use With Chemotherapy Drugs | 2017 | 48 |
| Polymer Patient Examination Glove | Class 1 | Powder Free Blue Nitrile Examination Gloves, Tested for Use With Chemotherapy Drugs, Power Free Pink Nitrile Examination Gloves (XS/S/M/L/XL);, Power Free Green Nitrile Examination Gloves (XS/S/M/L/XL), Power Free Purple Nitrile Examination Gloves (XS/S/M/L/XL), Powder Free Nitrile Gloves(Black), Powder Free Nitrile Gloves(White) and 5 more | 2013 | 83 |
| Vinyl Patient Examination Glove | Class 1 | Single-Use Medical Poly (Vinyl Chloride) Examination Glove (Clear, Non-Colored) | 2021 | 72 |
Clearances
7 clearances name Hebei Titans Hongsen Medical Technology Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240361 | 2024-04-04 | LZA | Traditional | This company |
| K223895 | 2023-03-23 | LZA | Traditional | This company |
| K221374 | 2022-10-26 | LYY | Traditional | This company |
| K212097 | 2021-08-18 | FXX | Traditional | This company |
| K211229 | 2021-07-29 | LYZ | Traditional | This company |
| K182043 | 2018-09-21 | LYZ | Traditional | This company |
| K181130 | 2018-08-10 | LZC | Traditional | This company |
| K163146 | 2017-02-13 | LZC | Traditional | Hebei Hongsen Plastics Technology Co., Ltd. |
| K150340 | 2015-06-18 | LZA | Traditional | Hebei Hongsen Plastics Technology Co., Ltd. |
| K131440 | 2013-09-25 | LZA | Traditional | Hebei Hongsen Plastics Technology Co., Ltd. |
| K110921 | 2011-04-15 | LZA | Traditional | Cardinal Health |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Factory area | 87,830.2 m² |
| Main products | Disposable nitrile gloves, Medical nitrile gloves, Industrial nitrile gloves, Vinyl gloves, Cleanroom nitrile gloves |
| Certifications | FDA 510k, EN455, EN374, (EU)2017/745 MDR, ISO 9001, ISO 13485, ISO 14001 |
| Export markets | Over 60 countries |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Hebei Lufen Tech Co., Limited | 12 |
| Ningjin Runboda Medical Protective Products Co., Ltd. | 8 |
| Kimlead Hygiene Products (Hebei) Co., Ltd. | 5 |
| Hebei Grandeast Plastic Products Co Ltd | 1 |
| Hebei Hongtai Plastic Products Co., Ltd. | 1 |
| Hebei Handform Medical Products Co., Ltd. | 1 |
| Hebei Changsheng Plastic Products Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.