Kgm Gloves Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Kgm Gloves Sdn. Bhd. makes
Kgm Gloves Sdn. Bhd. manufactures powder-free nitrile examination gloves in blue, designed for single-use medical and clinical applications to reduce powder-related risks and skin irritation.
The company’s powder-free nitrile 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 US.
Catalogue
Powder Free Nitrile Examination Gloves (Blue) Ref K220284
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kgm Gloves Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Kgm Gloves Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kgm Gloves Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Kgm Gloves Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Kgm Gloves Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kgm Gloves Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Kgm Gloves Sdn. Bhd. in the registry?
The most recently registered devices listed for Kgm Gloves Sdn. Bhd. include Powder Free Nitrile Examination Gloves (Blue).