Top Quality Glove Sdn. Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Top Quality Glove Sdn. Bhd makes
Top Quality Glove Sdn. Bhd manufactures thermoplastic polyethylene examination (TPE) gloves, designed for single-use medical and clinical procedures. These gloves are intended to provide barrier protection for healthcare professionals during patient examinations and treatments.
The company’s TPE examination gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Top Quality Glove Sdn. Bhd have in the registry?
The registry currently lists 1 device for Top Quality Glove Sdn. Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Top Quality Glove Sdn. Bhd's devices?
Among its 1 most recently registered device, Top Quality Glove Sdn. Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Top Quality Glove Sdn. Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Top Quality Glove Sdn. Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Top Quality Glove Sdn. Bhd in the registry?
The most recently registered devices listed for Top Quality Glove Sdn. Bhd include THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE.