Data / Medical devices / Canada / Hygie Canada Inc.
Hygie Canada Inc.: FDA-registered device maker in Drummondville Quebec, Canada, 2 510(k) clearances
Hygie Canada Inc. is registered with the FDA (registration 3008221237) in Drummondville Quebec, Canada. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008221237
- Address
- 800 Rocheleau St Bureau 204, Drummondville Quebec, Canada, J4Y 0E3
- Owner or operator
- Hygie Canada Inc. (10046551)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- April 7, 2014
- Registered through
- 2026
- Brand names listed
- Accessories Plate for Commode, Bedpan Kit, Bedpan ProHy21 Kit, Bedpan Seat Hy21, Bedpan/Commode Hygienic Cover, GO GLOV Disposable Dry Glove, GO PEE Kit, GO PEE Refill and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Commode, Wheelchair | INB | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Bedpan | FOB | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Scale, Sponge, Surgical, Electrically-Powered | MRL | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Urinal | FNP | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2020 | K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| February 6, 2017 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bedpan
- All makers of Scraper, Tongue
- All makers of Urinal
- All makers of Scale, Sponge, Surgical, Electrically-Powered
- All makers of Fiber, Medical, Absorbent
- All makers of Basin, Emesis
Updated August 5, 2020. 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.