Gauke International Trading Co., Ltd.
Registered establishment in Wuhan, Hubei, China. 36 device types.
Gauke International Trading Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Forceps, Pad, Eye and 34 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | GAUKE INTERNATIONAL TRADING CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3026263452 |
| FEI number | 3026263452 |
| Establishment type | Repacker / relabeller, Exporter |
Chinese Registration
| Chinese legal name | 武汉必凯尔救助用品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Wuhan |
|---|---|
| Province | Hubei |
| Address | ROOM 201-1, BUILDING 8, NO.10 FENGSHUO ROAD, QIAOKOU DISTRICT |
| Postal code | 430035 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shield, Hand Towel, Shoe Cover, Drape | 2024 | 439 |
| Anaerobic Box Glove | Class 1 | Gloves | 2024 | 10 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Tips, Cotton Swabs | 2024 | 186 |
| Bandage, Cast | Class 1 | First ftjd Dressing Bandages | 2024 | 81 |
| Bandage, Elastic | Class 1 | Conforming Elastic Bandages, Crepe Bandages | 2024 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | Antiseptic Wipes, Antiseptic Towelette | 2024 | 41 |
| Bedding, Disposable, Medical | Class 1 | First Aid Blanket | 2024 | 308 |
| Cotton, Roll | Class 1 | Cotton Ball, Zig-Zag Cotton Roll, Cotton, Cotton Roll | 2024 | 107 |
| Device, Finger-Sucking | Class 1 | Splint, Wire Splint | 2024 | 4 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Prep Pad, Pads, Povidone Iodine Prep Pads | 2024 | 197 |
| Dressing, Compression | Class 1 | Sterile Gauze Swabs, Bandage Compress, Burn Dressing, Sterile Absorbent Compress, Non-Adherent Pad | 2024 | 87 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Bum Relieve, Burn Dressing, Bum Gel | 2024 | 118 |
| Dressing, Wound, Occlusive | Class 1 | Transparent Wound Dressing, Wound Dressing, Cheat Seal | 2024 | 183 |
| Fentanyl And Other Opioid Protection Glove | Class 1 | Polymer Patient Examination Glove | 2026 | 29 |
| Finger Cot | Class 1 | Finger Cover | 2024 | 29 |
| First Aid Kit With Drug | Class N | First Aid Kit With Drug | 2024 | 57 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit | 2024 | 132 |
| Forceps | Class 1 | Forceps/Tweezers | 2024 | 99 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Compress, Gauze Sponges, Trauma Pad, Gauze Swabs, Abd Pad | 2024 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Gauze Sponge | 2024 | 67 |
| Mask, Oxygen | Class 1 | Mask, Oxygen | 2024 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | CPR Mask | 2024 | 72 |
| Mask, Scavenging | Class 1 | Face Mask | 2024 | 158 |
| Mask, Surgical | Class 2 | Face mask w/shield, Face Mask with Ear Loop and Plastic Shield | 2026 | 125 |
| Medical Glove, Specialty | Class 1 | Polymer Patient Examination Glove | 2026 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Polymer Patient Examination Glove | 2026 | 32 |
| Pack, Hot Or Cold, Disposable | Class 1 | Cold Compress Pack, Heat Pack | 2024 | 176 |
| Pad, Alcohol, Device Disinfectant | Class U | Alcohol Pad | 2024 | 49 |
| Pad, Eye | Class 1 | Eye Covering | 2024 | 100 |
| Polymer Patient Examination Glove | Class 1 | Examination glove, Polymer Patient Examination Glove | 2026 | 83 |
| Scissors, General, Surgical | Class 1 | Scissors | 2024 | 83 |
| Sling, Arm | Class 1 | Triangular bandages | 2024 | 126 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | Gauke Brand Splint Roll | 2024 | 62 |
| Stethoscope, Manual | Class 1 | Stethoscope | 2024 | 64 |
| Tape And Bandage, Adhesive | Class 1 | Triangular Bandage, Roller Bandage, Adhesive Tape, Sterile Adhesive Bandage | 2024 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | CAT Tourniquet | 2024 | 124 |
Clearances
No clearance names Gauke International Trading Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213040 | 2022-04-27 | LZA | Special | Guangdong Kingfa Medical SCI.&Tech. Co., Ltd. |
| K170393 | 2017-05-09 | LZA | Traditional | Zibo Chengxun Automatic Device Co., Ltd. |
| K153496 | 2016-06-15 | FXX | Traditional | Xiantao Rayxin Medical Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Main products | First aid kits, Bandages, Wound dressing, Protective equipment, Disposable gloves |
| Certifications | CE, UKCA, FDA, ISO 13485, IATF 16949, MDSAP, MDR, TGA, NMPA, BSCI, ISO 14001 |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.