# Gauke International Trading Co., Ltd. (foreign exporter, Wuhan Hubei, CN): 5 new FDA device listings, incl. polymer patient examination glove

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Gauke International Trading Co., Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Wuhan Hubei, CN |
| New listings | 5 |
| Devices | Polymer Patient Examination Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Medical Glove, Specialty; Fentanyl And Other Opioid Protection Glove; Mask, Surgical |
| Product codes | LZA, OPJ, LZC, QDO, FXX |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, General, Plastic Surgery |
| Brand names | Polymer Patient Examination Glove; Face Mask with Ear Loop and Plastic Shield; Face mask w/shield |
| First new listing | 2026-07-23 |
| Latest new listing | 2026-08-24 |
| FDA registration number | 3026263452 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.