Gauke (Hubei) Healthcare Co., Ltd.
Registered establishment in Huanggang, Hubei, China. 36 device types.
Gauke (Hubei) Healthcare Co., Ltd. is a contract manufacturer 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 (HUBEI) HEALTHCARE CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3034605486 |
| FEI number | 3034605486 |
| Establishment type | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
Location
| City | Huanggang |
|---|---|
| Province | Hubei |
| Address | No. 8, Jiangbei Highway |
| Postal code | 438000 |
| 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 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | cotton applicators, cotton tips | 2025 | 100 |
| Bandage, Cast | Class 1 | First aid dressing bandages | 2024 | 81 |
| Bandage, Elastic | Class 1 | Conforming elastic bandages, crepe bandages | 2024 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | Antiseptic towelette; Antiseptic wipes | 2024 | 41 |
| Bedding, Disposable, Medical | Class 1 | First aid blanket | 2024 | 308 |
| Cotton, Roll | Class 1 | Cotton ball, Cotton, Cotton roll, Zig-zag 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 | Bandage Compress; Burn Dressing; NON-Adherent PAD; Sterile Absorbent Compress; Sterile Gauze Swabs | 2024 | 87 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Burn Dressing; Burn Gel; Burn Relieve | 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 | 2024 | 57 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit | 2024 | 132 |
| Forceps | Class 1 | 2024 | 99 | |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze sponges, Gauze compress, Gauze swabs, ABD pad, Trauma 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 |
| 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 | 2025 | 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 | Adhesive Tape; Roller Bandage; Sterile Adhesive Bandage; Triangular Bandage | 2024 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | CAT Tourniquet | 2024 | 124 |
Clearances
No clearance names Gauke (Hubei) Healthcare Co., Ltd. as applicant. 2 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. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | First aid kits, Bandages, Wound care dressing, Personal protective equipment, Disposable gloves |
|---|---|
| Certifications | CE, UKCA, FDA, ISO 13485, IATF 16949, MDSAP, MDR, TGA, NMPA, BSCI, ISO 14001 |
| Export markets | Global market |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Winner Medical (Huanggang) Co., Ltd. | 9 |
| Hubei Junyan Medical Science & Technology Co., Ltd. | 5 |
| Hubei Rightway Technology Co., Ltd. | 2 |
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.