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Data / Medical devices / United States / Acme United Corp.

Acme United Corp.: FDA-registered device maker in Rocky Mount, NC, United States, 3 510(k) clearances

Acme United Corp. is registered with the FDA (registration 1025972) in Rocky Mount, NC, United States. It lists 31 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 20, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1025972
FEI number
1030186
Address
2280 Tanner Rd, Rocky Mount, NC, United States, 27801
Owner or operator
ACME UNITED CORP. (1217843)
Roles
Manufacturer, Repackager or relabeler
First device listed
July 30, 1992
Registered through
2026
Brand names listed
Finger Cot, First Aid Only, First Aid Only Pac-Kit Physicians Care, First Aid Only Burn Gel, First Aid Only Vented Chest Seal, Pac-Kit, Physicans Care, Physicians CAre and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Finger CotLZB1Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNManufacturer, Repackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeleraccessdata.fda.gov
Mouthpiece, BreathingBYP1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Repackager or relabeleraccessdata.fda.gov
Pad, EyeHMP1Repackager or relabeleraccessdata.fda.gov
Personal Protection KitPXC1Manufactureraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Shoe And Shoe Cover, ConductiveBWP1Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Repackager or relabeleraccessdata.fda.gov
Snake Bite Suction KitKYP1Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Noninflatable, External, SterileFYH1Repackager or relabeleraccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Thermometer, Clinical Color ChangeFQZ1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeleraccessdata.fda.gov
Valve, Non-RebreathingCBP2Repackager 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
July 20, 2017K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorLZASubstantially EquivalentShandong Xingyu Gloves Co., Ltd.accessdata.fda.gov
June 15, 2016K153496Disposable Surgical Face MaskFXXSubstantially EquivalentXiantao Rayxin Medical Products Co., Ltd.accessdata.fda.gov
July 22, 2010K083418CPR MASKCBPSubstantially EquivalentFirstar Healthcare Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated July 20, 2017. 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.