First Glove Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What First Glove Sdn. Bhd. makes
First Glove Sdn. Bhd. manufactures powder-free nitrile examination gloves, designed for medical and clinical use to reduce allergic reactions and skin irritation. The product is marketed under the First Glove Blue brand and is intended for single-use protective barriers in healthcare settings.
The company’s nitrile examination gloves are classified as Class I medical devices under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the US, and the product is registered in the FDA’s 510(k) database.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does First Glove Sdn. Bhd. have in the registry?
The registry currently lists 1 device for First Glove Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list First Glove Sdn. Bhd.'s devices?
Among its 1 most recently registered device, First Glove Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do First Glove Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for First Glove Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from First Glove Sdn. Bhd. in the registry?
The most recently registered devices listed for First Glove Sdn. Bhd. include First Glove Blue Nitrile Examination Gloves Powder Free.