EIKON DEVICE INC.

FDA Device Registration & Listing · Kingston Ontario, CA · Registration 3010363542

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010363542
FEI Number
3010363542
Entity Name
EIKON DEVICE INC.
City/State/Country
Kingston Ontario, CA
Establishment Address
689 Innovation Drive, Kingston Ontario K7K 7E6, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Eikon Device Inc. (Owner Number: 10044469)
Owner / Operator Contact Address
689 Innovation Drive, Kingston, CA-ON K7K7E6, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K112266
PMA Number
N/A

All Registered Proprietary Names

Medicom Non-Sterile Gauze - pkg. 200 Dynarex PowderFree Nitrile Gloves - S, M, L, XL Dynarex PowderFree Latex Gloves - S, M, L, XL Eikon Wraps - Latex Free - 1” Camo Pack - Box of 24 Eikon Wraps - Latex Free - 2” Black Pack - Box of 12 Dynarex Self-Adherent Bandage Retainers Eikon Wraps - Latex Free - 1” Black Pack - Box of 24 Eikon Wraps - Latex Free - 2” Camo Pack - Box of 12 Dynarex Non-Adherent Pad - 17" x 24" Graham FlexAir Plus Disposable Pillow - case of 50 Graham pillowcase Tissue/Poly - blue - case of 100 Eikon Drape Sheet - 40 x 60 - Studio Grey Eikon Bib - 13 x 18 - Medical Blue Eikon Bib - 13 x 18 - Medical Blue - Case of 500 Eikon Bib - 13 x 18 - Studio Grey - Case of 500 Eikon Drape Sheet - 40 x 60 - Medical Blue Eikon Drape Sheet - 40 x 48 Eikon Drape Sheet - 40 x 48 - Studio Grey Eikon Bib - 13 x 18 - Studio Grey - Bag of 125 Dynarex PowderFree Vinyl Gloves - S, M, L, XL Defend PowderFree Latex Gloves - XS, S, M, L, XL Precision Violet Nitrile Gloves - XS, S, M, L, XL Black Lightning Nitrile Gloves - S, M, L, XL, XXL Shadow & Night Angel PowderFree Nitrile Gloves - XS, S, M, L, XL MicroFlex MidKnight Nitrile Gloves - XS, S, M, L, XL Eikon Premium Black Nitrile Powder Free Examination Gloves (XS, S, M, L, XL) Eikon Standard Premium Nitrile Powder Free Examination Gloves (XS, S, M, L, XL) Dynarex Non-Adherent Bandage - Sterile - 3" x 8" - box of 50 Crosstex Indicator Strip Black Lightning Gloves - Small, Medium Crosstex Sterilization Pouches Defend Sterilization Pouch - 2 1/4" x 4" Defend Sterilization Pouch - 3 1/2" x 10" Defend Sterilization Pouch - 2" x 7 3/4" Defend Sterilization Pouch - 3 1/2" x 5 1/4" Defend Sterilization Pouch - 5 1/4" x 10" Defend Sterilization Pouch - 2 3/4" x 10" Tatu-Derm Bandage 3M Micropore & Transpore Tape Dynarex Tape Saniderm Graham drape sheet Defend Breathe-EZ Mask Koda Glove Vitex Stretch Vinyl Gloves - XS, S, M, L, XL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2013-06-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-06-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2013-06-17
FQM Bandage, Elastic General Hospital Class 1 880.5075 2013-06-17
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2013-06-17
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2013-06-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2013-06-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-04-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-06-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-06-17
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2013-06-17
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2013-06-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-12-17
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-04-15
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2013-12-17
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2013-06-17
FME Gown, Examination General Hospital Class 1 880.6265 2013-06-17
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2013-06-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-12-22
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2020-12-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-12-22
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2014-04-15

Official Correspondent

Dean Byrnes

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

Eikon Device Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010363542. Last updated year: 2026. Please use registration number 3010363542 when referencing this establishment in official correspondence.
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