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Allmed Industrial Limited: FDA-registered device maker in Shenzhen City Guangdong, China, 19 510(k) clearances

Allmed Industrial Limited is registered with the FDA (registration 3011089435) in Shenzhen City Guangdong, China. It lists 42 device types. The FDA files 19 510(k) clearances under its listings, the newest dated September 29, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3011089435
Address
19F, Block A, Taurus Plaza No.8 Taoyuan Rd, Nanshan District, Shenzhen City Guangdong, China, 518055
Owner or operator
ALLMED MEDICAL PRODUCTS CO., LTD. (9033718)
Roles
Exporter to the US, Manufacturer
First device listed
April 3, 2001
Registered through
2026
Brand names listed
Abdominal Pad, Absorbent Cotton Wool, Absorbent Gauze Roll 100% cotton, AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Pairs, AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles, AloeTouch 9” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles, Antibac bandages, Applicator and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Exporter to the USaccessdata.fda.gov
Brush, Dermabrasion, ManualGED1Exporter to the USaccessdata.fda.gov
Closure, Wound, AdhesiveMGO1Exporter to the USaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the USaccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the USaccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Drape, Surgical, ExemptPUI2Exporter to the USaccessdata.fda.gov
Dressing, CompressionMHW1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter to the USaccessdata.fda.gov
Finger CotLZB1Exporter to the USaccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the USaccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Gauze/Sponge, InternalEFQUExporter to the USaccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Exporter to the USaccessdata.fda.gov
Marker, SkinFZZ1Exporter to the USaccessdata.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
Neurosurgical PaddieHBA2Exporter to the USaccessdata.fda.gov
Pad, EyeHMP1Exporter to the USaccessdata.fda.gov
Pad, Menstrual, UnscentedHHD1Exporter to the USaccessdata.fda.gov
Pick, MassagingJET1Manufactureraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Scissors, Medical, DisposableJOK1Exporter to the USaccessdata.fda.gov
Sling, ArmILI1Exporter to the USaccessdata.fda.gov
Suture Removal KitMCZ1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Exporter to the USaccessdata.fda.gov
Tracheostomy And Nasal Suctioning KitLRQ1Exporter to the USaccessdata.fda.gov
Tracheostomy Cleaning TrayOGV2Exporter to the USaccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Exporter to the USaccessdata.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
September 29, 2022K221637Surgical Gown (Sterile); Surgical Gown (Non-sterile)FYASubstantially EquivalentAllmed Medical (Hubei) Protective Products Co., Ltd.accessdata.fda.gov
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
March 10, 2021K202411Surgical MaskFXXSubstantially EquivalentAllmed Medical Products Co., Ltd.accessdata.fda.gov
March 17, 2020K191753Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)LZASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
March 25, 2015K142892Powder-free Clear Vinyl Patient Examination GlovesLYZSubstantially EquivalentShenyi (Shandong) Plastic Products Co., Ltd.accessdata.fda.gov
September 26, 2014K140369MEDLINE NEURO SPONGEHBASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 16, 2012K121992POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORLZASubstantially EquivalentXinwei (Shandong) Plastic and Rubber Products Co.,accessdata.fda.gov
April 12, 2012K113583CURAD ANTIBACTERIAL BANDAGEFROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
January 7, 2010K093349MEDLINE CURAD WOUND DRESSINGSFROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 20, 2005K052720MEDLINE IODOFORM PACKING STRIPSFROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 17, 2002K012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414FROSubstantially EquivalentDynarex Corp.accessdata.fda.gov
March 30, 2001K010097POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZASubstantially EquivalentShen Wei (Usa), Inc.accessdata.fda.gov
October 24, 2000K003091MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOWLYZSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
February 25, 1994K940339IODOFORM PACKAGING STRIPFROSubstantially EquivalentAlbahealth Productsaccessdata.fda.gov
June 24, 1993K930697MEDLINE STERILE GAUZE SPONGESNADSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 15, 1986K861154ALBA HEALTH CARE PLAIN PACKING STRIPEFQSubstantially EquivalentAlba Health Careaccessdata.fda.gov
March 12, 1985K850241ALBA HEALTH CARE NON-ADHERING DRESSINGFROSubstantially EquivalentAlba Health Careaccessdata.fda.gov
June 2, 1983K830269FLORET NEURO SPONGEEFQSubstantially EquivalentRitmed, Inc.accessdata.fda.gov
February 4, 1982K813535XEROFORM DRESSINGFROSubstantially EquivalentW.G. Whitney Corp.accessdata.fda.gov

Compare with other makers

Updated September 29, 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.