FDA device listing
Nitrile Examination Glove: KG-1104; Nitrile Examination Glove: KG-1303; Nitrile Examination Glove: KG-1106,Powder Free…
FDA device listing 1633903751 · Guangdong VyiMed Co., Ltd.
Key facts
| Proprietary names | Nitrile Examination Glove: KG-1104; Nitrile Examination Glove: KG-1303; Nitrile Examination Glove: KG-1106,Powder Free Nitrile Examination Gloves |
|---|---|
| Owner/operator | Guangdong VyiMed Co., Ltd. |
| Owner/operator number | 10090040 |
| Premarket submissions | K221887 |
| Product codes | LZA |
| Device names | LZA - Polymer Patient Examination Glove |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | GUANGDONG VYIMED CO., LTD. |
| Establishment registrations | 3030671502 |
| FEI numbers | 3030671502 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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