High Momentum Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 4
What High Momentum Sdn Bhd makes
High Momentum Sdn Bhd manufactures examination gloves, including powder-free and powdered versions made from nitrile and latex. These products are designed for medical and clinical use to provide barrier protection during procedures.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. The manufacturer is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Latex Powdered Examination Glove Ref K060858
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does High Momentum Sdn Bhd have in the registry?
The registry currently lists 4 devices for High Momentum Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list High Momentum Sdn Bhd's devices?
Among its 4 most recently registered devices, High Momentum Sdn Bhd has devices listed in FDA 510(k) (4 devices).
What risk classes do High Momentum Sdn Bhd's devices fall under?
Among its 4 most recently registered devices, the classes recorded for High Momentum Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from High Momentum Sdn Bhd in the registry?
The most recently registered devices listed for High Momentum Sdn Bhd include MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES, MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES, LATEX POWDERED EXAMINATION GLOVE and MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES.