FDA device listing
PI Hybrid Micro
FDA device listing 1796888646 · ANSELL HEALTHCARE PRODUCTS LLC
Key facts
| Proprietary names | PI Hybrid Micro |
|---|---|
| Owner/operator | ANSELL HEALTHCARE PRODUCTS LLC |
| Owner/operator number | 8020065 |
| Premarket submissions | K231902 |
| Product codes | KGO, OPJ |
| Device names | KGO - Surgeon'S Gloves, OPJ - Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4460, 880.6250 |
| Review panels | General Hospital, General & Plastic Surgery |
| Registered establishments | ANSELL HEALTHCARE PRODUCTS LLC, ANSELL LANKA (PVT.), LTD., ANSELL N.P. SDN. BHD., ANSELL SEREMBAN SDN. BHD, Ansell Sterile Solutions Pvt. Ltd, ANSELL (THAILAND) LTD. |
| Establishment registrations | 8041180, 8043736, 9610406, 3010436932, 3011209798, 3024706752 |
| FEI numbers | 3002806370, 3002806389, 3003221560, 3010436932, 3011209798, 3024706752 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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