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Data / Medical devices / China / GFA Production Xiamen Co., Ltd.

GFA Production Xiamen Co., Ltd.: FDA-registered device maker in Tong An, Xiamen Fujian, China, 6 510(k) clearances

GFA Production Xiamen Co., Ltd. is registered with the FDA (registration 3008384335) in Tong An, Xiamen Fujian, China. It lists 30 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 24, 2022. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch GFA Production Xiamen Co., Ltd.
FDA registration number
3008384335
Address
#20 HuLi Industrial Park, Mei Xi Dao, Tong An, Xiamen Fujian, China, 361100
Owner or operator
GFA Production Xiamen Co., Ltd. (9073017)
Roles
Manufacturer, Repackager or relabeler
First device listed
May 6, 2010
Registered through
2026
Brand names listed
Disposable Face Mask

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Repackager or relabeleraccessdata.fda.gov
Bandage, CastITG1Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Finger CotLZB1Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNManufactureraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufactureraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Manufactureraccessdata.fda.gov
Pad, EyeHMP1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Protector, Skin PressureFMP1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Repackager or relabeleraccessdata.fda.gov
Stapler, SkinQQS1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Thermometer, Clinical Color ChangeFQZ1Repackager or relabeleraccessdata.fda.gov
Valve, Non-RebreathingCBP2Repackager or relabeleraccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Repackager 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
March 24, 2022K202903Surgical Face MaskFXXSubstantially EquivalentRizhao Sanqi Medical & Health Articles Co., Ltd.accessdata.fda.gov
July 30, 2021K210691Disposable Nitrile Medical Examination GloveLZASubstantially EquivalentJiangsu Cureguard Glove Co., Ltd.accessdata.fda.gov
November 17, 2017K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)CBPSubstantially EquivalentXiamen Compower Medical Tech. Co., Ltd.accessdata.fda.gov
September 19, 2017K163518Digital ThermometerFLLSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
October 8, 2010K102161BLUE SAIL INNOVATIONLYZSubstantially EquivalentShandong Blue Sail Innovation Co., Ltd.accessdata.fda.gov
February 22, 2007K070076POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)LYZSubstantially EquivalentJiangsu Cureguard Glove Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated March 24, 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.