Iconic Medicare Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 3
What Iconic Medicare Sdn Bhd makes
Iconic Medicare Sdn Bhd manufactures single-use disposable gloves, including latex, nitrile, and chemotherapy-resistant nitrile variants. The gloves are designed for medical and laboratory applications, with specific formulations for handling hazardous substances like chemotherapy drugs and fentanyl citrate.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the US, adhering to applicable US regulatory standards for these device categories.
Catalogue
Iconic Latex Glove Ref K221648
Regimes: 510(k) Registry: 510(k)Iconic Nitrile Glove Ref K212182
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Iconic Medicare Sdn Bhd have in the registry?
The registry currently lists 3 devices for Iconic Medicare Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iconic Medicare Sdn Bhd's devices?
Among its 3 most recently registered devices, Iconic Medicare Sdn Bhd has devices listed in FDA 510(k) (3 devices).
What risk classes do Iconic Medicare Sdn Bhd's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Iconic Medicare Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Iconic Medicare Sdn Bhd in the registry?
The most recently registered devices listed for Iconic Medicare Sdn Bhd include Iconic Latex Glove, Iconic Nitrile Glove and Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate.