Data / Medical devices / China / Hebei Titans Hongsen Medical Technology Co.,ltd
Hebei Titans Hongsen Medical Technology Co.,ltd: FDA-registered device maker in Xingtai Hebei, China, 7 510(k) clearances
Hebei Titans Hongsen Medical Technology Co.,ltd is registered with the FDA (registration 3010582952) in Xingtai Hebei, China. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010582952
- Address
- Eastern Industrial Zone Nangong, Xingtai Hebei, China, 051800
- Owner or operator
- HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO.,LTD (10045284)
- Roles
- Manufacturer
- First device listed
- November 3, 2013
- Registered through
- 2026
- Brand names listed
- Examination Gloves, Powder Free Blue Nitrile Examination Gloves, Tested for Use With Chemotherapy Drugs, Powder Free Blue Nitrile Gloves, Tested For Use With Chemotherapy Drugs, Powder Free Nitrile Gloves(Black), Powder Free Nitrile Gloves(Cobalt Blue), Powder Free Nitrile Gloves(Ice Blue), Powder Free Nitrile Gloves(White), Powder Free Nitrile Patient Examination Gloves, Blue and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2024 | 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) | LZA | Substantially Equivalent | Hebei Titans Hongsen Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 21, 2018 | K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | LYZ | Substantially Equivalent | Hebei Titans Hongsen Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 10, 2018 | K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Hebei Titans Hongsen Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 13, 2017 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Hebei Hongsen Plastics Technology Co, Ltd. | accessdata.fda.gov |
| June 18, 2015 | K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | LZA | Substantially Equivalent | Hebei Hongsen Plastics Technology Co, Ltd. | accessdata.fda.gov |
| September 25, 2013 | K131440 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hebei Hongsen Plastics Technology Co, Ltd. | accessdata.fda.gov |
| April 15, 2011 | K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
Updated April 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.