Tk Hitech Technology Co., Ltd.
ThailandFDA applicant, unverified
- Devices
- 1
What Tk Hitech Technology Co., Ltd. makes
Tk Hitech Technology Co., Ltd. manufactures Nitrile Examination Gloves, a type of single-use protective barrier for medical and clinical procedures.
These gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
BIOTECH Nitrile Examination Gloves Ref K202419
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tk Hitech Technology Co., Ltd. have in the registry?
The registry currently lists 1 device for Tk Hitech Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tk Hitech Technology Co., Ltd.'s devices?
Among its 1 most recently registered device, Tk Hitech Technology Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Tk Hitech Technology Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Tk Hitech Technology Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Tk Hitech Technology Co., Ltd. in the registry?
The most recently registered devices listed for Tk Hitech Technology Co., Ltd. include BIOTECH Nitrile Examination Gloves.