Quality Gallant Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 4
What Quality Gallant Sdn. Bhd. makes
Quality Gallant Sdn. Bhd. manufactures single-use examination gloves, including powdered latex, powder-free latex, and powder-free nitrile varieties in blue and white colors. These gloves are designed for medical and clinical examinations to provide barrier protection and reduce allergenic risks.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Powdered Latex Examination Gloves Ref K071323
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Powder Free Latex Examination Gloves Ref K071322
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quality Gallant Sdn. Bhd. have in the registry?
The registry currently lists 4 devices for Quality Gallant Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quality Gallant Sdn. Bhd.'s devices?
Among its 4 most recently registered devices, Quality Gallant Sdn. Bhd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Quality Gallant Sdn. Bhd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Quality Gallant Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Quality Gallant Sdn. Bhd. in the registry?
The most recently registered devices listed for Quality Gallant Sdn. Bhd. include POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES, POWDERED LATEX EXAMINATION GLOVES, POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES and POWDER FREE LATEX EXAMINATION GLOVES.