Data / Medical devices / Canada / Eikon Device Inc.
Eikon Device Inc.: FDA-registered device maker in Kingston Ontario, Canada, 17 510(k) clearances
Eikon Device Inc. is registered with the FDA (registration 3010363542) in Kingston Ontario, Canada. It lists 19 device types. The FDA files 17 510(k) clearances under its listings, the newest dated May 28, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010363542
- Address
- 689 Innovation Drive, Kingston Ontario, Canada, K7K 7E6
- Owner or operator
- Eikon Device Inc. (10044469)
- Roles
- Exporter to the US
- First device listed
- June 17, 2013
- Registered through
- 2026
- Brand names listed
- 3M Micropore & Transpore Tape, Black Lightning Gloves - Small, Medium, Black Lightning Nitrile Gloves - S, M, L, XL, XXL, Crosstex Indicator Strip, Crosstex Sterilization Pouches, Defend Breathe-EZ Mask, Defend PowderFree Latex Gloves - XS, S, M, L, XL, Defend Sterilization Pouch - 2 1/4" x 4" and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2019 | K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| May 8, 2012 | K112266 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | LYZ | Substantially Equivalent | Shandong Zhiyuan Medical Products Co., Ltd. | accessdata.fda.gov |
| July 16, 2010 | K100603 | RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| June 25, 2010 | K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| July 7, 2009 | K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| December 27, 2007 | K071886 | SELF SEAL STERILIZATION POUCH | FRG | Substantially Equivalent | Shanghai Jianzhong Medical Packaging Co., Ltd. | accessdata.fda.gov |
| October 4, 2007 | K071740 | CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES | LZA | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| July 17, 2006 | K061553 | NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| May 1, 2006 | K060073 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 20, 2005 | K051291 | NON-STERILE SURGICAL MASK | FXX | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
| December 30, 2002 | K022091 | BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES | LYZ | Substantially Equivalent | Tangshan Zhonghong Pulin Group Co., Ltd. | accessdata.fda.gov |
| May 22, 2000 | K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| October 15, 1998 | K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| May 6, 1997 | K970794 | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| March 12, 1996 | K955426 | STERITEC CROSS-CHECKS | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| December 22, 1994 | K941327 | CROSSTEX SELF-SEALING STERILIZATION POUCH | KCT | Substantially Equivalent | Cross Country Paper Products Corp. | accessdata.fda.gov |
| November 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | Substantially Equivalent | Ashton Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Bandage, Elastic
- All makers of Latex Patient Examination Glove
- All makers of Dressing, Wound, Hydrophilic
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Mask, Surgical
Updated May 28, 2019. 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.