One Glove Industrial Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 4
What One Glove Industrial Sdn Bhd makes
One Glove Industrial Sdn Bhd manufactures non-sterile patient examination gloves in black, violet, and white nitrile, designed for medical and clinical use without powder.
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 US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does One Glove Industrial Sdn Bhd have in the registry?
The registry currently lists 4 devices for One Glove Industrial Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list One Glove Industrial Sdn Bhd's devices?
Among its 4 most recently registered devices, One Glove Industrial Sdn Bhd has devices listed in FDA 510(k) (4 devices).
What risk classes do One Glove Industrial Sdn Bhd's devices fall under?
Among its 4 most recently registered devices, the classes recorded for One Glove Industrial Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from One Glove Industrial Sdn Bhd in the registry?
The most recently registered devices listed for One Glove Industrial Sdn Bhd include Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile, Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile, Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile and White Nitrile Powder-Free Patient Examination Glove, Non Sterile.