FDA device listing
Aurelia,Fantastik,King,Medic Dent,Supergloves,Supermax
FDA device listing 1549975880 · SUPERMAX GLOVE MANUFACTURING SDN BHD.
Key facts
| Proprietary names | Aurelia,Fantastik,King,Medic Dent,Supergloves,Supermax |
|---|---|
| Owner/operator | SUPERMAX GLOVE MANUFACTURING SDN BHD. |
| Owner/operator number | 9010828 |
| Premarket submissions | K013953 |
| Product codes | LYY |
| Device names | LYY - Latex Patient Examination Glove |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | MAXTER HEALTHCARE PTE LTD, SUPERMAX GLOVE MANUFACTURING SDN BHD |
| Establishment registrations | 9680710, 3035455506 |
| FEI numbers | 3002808252, 3035455506 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database