Skip to the page
Get started free

Data / Medical devices / China / Gauke International Trading Co., Ltd.

Gauke International Trading Co., Ltd.: FDA-registered device maker in Wuhan Hubei, China, 3 510(k) clearances

Gauke International Trading Co., Ltd. is registered with the FDA (registration 3026263452) in Wuhan Hubei, China. It lists 36 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 27, 2022. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Gauke International Trading Co., Ltd.
FDA registration number
3026263452
Address
Room 201-1, Building 8, No.10 Fengshuo Road, Qiaokou District, Wuhan Hubei, China, 430035
Owner or operator
GAUKE INTERNATIONAL TRADING CO., LTD. (10092137)
Roles
Exporter to the US, Repackager or relabeler
First device listed
December 8, 2024
Registered through
2026
Brand names listed
Abd Pad, Adhesive Tape, Alcohol Pad, Alcohol Prep Pad, Antiseptic Towelette, Antiseptic Wipes, Bandage Compress, Bum Gel and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Anaerobic Box GloveJTM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Bandage, CastITG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Device, Finger-SuckingLQX1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Exporter to the USaccessdata.fda.gov
Finger CotLZB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the US, Repackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Medical Glove, SpecialtyLZC1Exporter to the USaccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUExporter to the US, Repackager or relabeleraccessdata.fda.gov
Pad, EyeHMP1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Scissors, General, SurgicalLRW1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Exporter to the US, Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 27, 2022K213040Nitrile 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 DrugsLZASubstantially EquivalentGuangdong Kingfa Sci. & Tech.Co., Ltd.accessdata.fda.gov
May 9, 2017K170393Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)LZASubstantially EquivalentZibo Chengxun Automatic Device Co., Ltd.accessdata.fda.gov
June 15, 2016K153496Disposable Surgical Face MaskFXXSubstantially EquivalentXiantao Rayxin Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

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.