Gallant Quality Sdn. Bhd.
MalaysiaFDA applicant, unverified FDA FEI 3006581410
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Gallant Quality Sdn. Bhd. makes
Gallant Quality Sdn. Bhd. manufactures powder-free nitrile examination gloves in black, designed for medical and clinical use to reduce latex allergens and provide durable protection during procedures.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway in the United States. The manufacturer is based in the US.
Catalogue
Powder Free Nitrile (Black) Examination Gloves Ref K151528
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3006581410
- Address
- LOT 1874, JALAN KAMPUNG DEW, TAIPING, PERAK
Frequently asked questions
How many devices does Gallant Quality Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Gallant Quality Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gallant Quality Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Gallant Quality Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Gallant Quality Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gallant Quality Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gallant Quality Sdn. Bhd. in the registry?
The most recently registered devices listed for Gallant Quality Sdn. Bhd. include Powder Free Nitrile (Black) Examination Gloves.