FDA device listing
AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Pairs,AloeTouch 12” Sterile Powder-Free Stretch Nitrile…
FDA device listing 1462997932 · ALLMED MEDICAL PRODUCTS CO., LTD.
Key facts
| Proprietary names | AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Pairs,AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles,AloeTouch 9” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles,CURAD Germ Shield Powder-Free Sterile Nitrile Exam Gloves,Pairs |
|---|---|
| Owner/operator | ALLMED MEDICAL PRODUCTS CO., LTD. |
| Owner/operator number | 9033718 |
| Premarket submissions | K191753 |
| Product codes | LZA, LZC |
| Device names | LZA - Polymer Patient Examination Glove, LZC - Medical Glove, Specialty |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | Allmed Industrial Limited, ALLMED MEDICAL PRODUCTS CO., LTD. |
| Establishment registrations | 3011089435, 3011862887 |
| FEI numbers | 3011089435, 3011862887 |
| Establishment operations | Contract Sterilizer, Repackager/Relabeler, Foreign Exporter |
| 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