FDA device listing
POWDER FREE STERILE LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA device listing 1102888915 · Hartalega NGC Sdn. Bhd. (Lot 39496)
Key facts
| Proprietary names | POWDER FREE STERILE LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
|---|---|
| Owner/operator | Hartalega NGC Sdn. Bhd. (Lot 39496) |
| Owner/operator number | 10090827 |
| Premarket submissions | K002593 |
| Product codes | KGO |
| Device names | KGO - Surgeon'S Gloves |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4460 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HARTALEGA NGC SDN. BHD. (LOT 39496) |
| Establishment registrations | 3019769825 |
| FEI numbers | 3019769825 |
| Establishment operations | 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