Data / Medical devices / China / Gauke (hubei) Healthcare Co., Ltd
Gauke (hubei) Healthcare Co., Ltd: FDA-registered device maker in Huanggang City Hubei, China, 2 510(k) clearances
Gauke (hubei) Healthcare Co., Ltd is registered with the FDA (registration 3034605486) in Huanggang City Hubei, China. It lists 36 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034605486
- Address
- No. 8, Jiangbei Highway TuanFeng Town, Huanggang City Hubei, China, 438000
- Owner or operator
- Gauke (Hubei) Healthcare Co., Ltd (10091992)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 22, 2024
- Registered through
- 2026
- Brand names listed
- ADHESIVE TAPE; ROLLER BANDAGE; STERILE ADHESIVE BANDAGE; TRIANGULAR BANDAGE, Alcohol pad, Alcohol prep pad; Pads; povidone iodine prep pads, Antiseptic towelette; Antiseptic wipes, BANDAGE COMPRESS; BURN DRESSING; NON-ADHERENT PAD; STERILE ABSORBENT COMPRESS; STERILE GAUZE SWABS, Burn Dressing; Burn Gel; Burn Relieve, CAT Tourniquet, CPR mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Anaerobic Box Glove | JTM | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Finger-Sucking | LQX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US | accessdata.fda.gov |
| Finger Cot | LZB | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2022 | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| May 9, 2017 | K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | LZA | Substantially Equivalent | Zibo Chengxun Automatic Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Disinfectant, Medical Devices
- All makers of Dressing, Wound, Occlusive
- All makers of Stethoscope, Manual
- All makers of Finger Cot
- All makers of Tape And Bandage, Adhesive
- All makers of Forceps
Updated April 27, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.