Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008221237

FEI Number

3008221237

Entity Name

Hygie Canada Inc.

City/State/Country

Drummondville Quebec, CA

Establishment Address

800 Rocheleau St, Bureau 204, Drummondville Quebec J4Y 0E3, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Hygie Canada Inc. (Owner Number: 10046551)

Owner / Operator Contact Address

1000 rue du Lux, Suite 210, Brossard, CA-QC J4Y 0E3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GO GLOV Disposable Dry Glove Hygienic Super Absorbent Powder Hygie Super-Absorbent Pad Hygie Extra-Absorbent Pad Hygie Wet Wash Gloves Hygienic Wet Wash Gloves Urinal Kit Urinal Bag Hygie Hy21 Urinal Support Uri ProHy21 Kit GO PEE Refill GO PEE Kit Urinal Hygienic Cover Hygie Classic Commode Chair Hygie Alu-Classic Commode Accessories Plate for Commode Seats for Commode Replacement Parts for Commode Hy21 Seat for Hygie Commode Chair/Pail Hy-SO Isolation Kit Hygie Absorbent Pads Hygie Hygienic Covers for Bedpan and Commode Hy21 Bedpan Support Toilet Hygienic Cover Hy-So Kit Hygienic Cover Dispenser Pail/Orthopedic Bedpan Hygienic Cover Bedpan Seat Hy21 Kit EBOLA Bedpan Kit Hygie Hy21 Bedpan Support Extender Bedpan ProHy21 Kit Bedpan/Commode Hygienic Cover Splatter Proof Pail Hygienic Garbage Bags Vomit Kit Vomit Hygienic Cover Hygie Hy21 Vomit Support GOVOM Vomit Bags Vom ProHy21 Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-09-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-09-19
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-09-19
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2022-07-22
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-11-09
FNP	Urinal	General Hospital	Class 1	880.6730	2015-11-09
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2014-04-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-06-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-06-27
FOB	Bedpan	General Hospital	Class 1	880.6730	2014-04-07
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2014-04-07

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: EMERGO GLOBAL REPRESENTATION LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Hygie Canada 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

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3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008221237. Last updated year: 2026. Please use registration number 3008221237 when referencing this establishment in official correspondence.