FDA device listing
Sterile Nitrile PF Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff,Sterile…
FDA device listing 1500719346 · HARTALEGA NGC SDN BHD
Key facts
| Proprietary names | Sterile Nitrile PF Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff,Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) |
|---|---|
| Owner/operator | HARTALEGA NGC SDN BHD |
| Owner/operator number | 10047371 |
| Premarket submissions | K251319 |
| Product codes | LZA, LZC, OPJ, QDO |
| Device names | LZA - Polymer Patient Examination Glove, LZC - Medical Glove, Specialty, OPJ - Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs, QDO - Fentanyl And Other Opioid Protection Glove |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | HARTALEGA NGC SDN BHD |
| Establishment registrations | 3011200663 |
| FEI numbers | 3011200663 |
| Establishment operations | 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