Ansell Canada Inc.

FDA Device Registration & Listing · Cowansville Quebec, CA · Registration 3003199637

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
3003199637
FEI Number
3003199637
Entity Name
Ansell Canada Inc.
City/State/Country
Cowansville Quebec, CA
Establishment Address
105 Rue Lauder, Cowansville Quebec J2K 2K8, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ANSELL HEALTHCARE PRODUCTS LLC (Owner Number: 8020065)
Owner / Operator Contact Address
2301 Robb Drive, Reno, NV 89523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K062764
PMA Number
N/A

All Registered Proprietary Names

GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS POWDER FREE NITRILE EXAMINATION GLOVE WHITE (colored) Micro-Touch Royal Blue Cobalt ® N19X

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-09-16
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-09-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2016-11-03
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2016-11-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2019-09-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-01-31
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-02-05
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2019-09-16
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-03-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-11-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-05-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-08-23
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-11-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-11-12
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2023-05-30
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-05-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-30
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-01-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-04-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2013-04-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-01-08
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-01-08
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-07-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2020-01-24
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2015-04-29
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2015-04-29
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2010-05-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-09-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-11-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-02-05
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-01-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-10-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-10-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-09-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2019-09-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-05-22
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2019-09-20
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-09-16

Official Correspondent

Don Cronk

US Agent Details

Don Cronk Email: don.cronk@ansell.com Phone: (775) 4707106

Related Public Records

Same Entity

ANSELL HEALTHCARE PRODUCTS LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9610406 ANSELL (THAILAND) LTD. THAILAND Krung Thep Maha Nakhon, TH
3010459874 Ansell Perry de Mexico S.A. de C.V. Cd. Juarez Chihuahua, MX
3009964047 ANSELL HEALTHCARE PRODUCTS LLC Iselin, NJ, US
3004125670 Ansell Sandel Medical Solutions LLC CHATSWORTH, CA, US
8043736 ANSELL N.P. SDN. BHD. MELAKA, MY

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

Similar Registrations

Registration Number Establishment Name Location
3030671502 GUANGDONG VYIMED CO., LTD. Qingyuan Guangdong, CN
9610406 ANSELL (THAILAND) LTD. THAILAND Krung Thep Maha Nakhon, TH
3026062711 RMKH GLOVE (CAMBODIA) CO., LTD. Bavet City Svay Rieng, KH
3043739177 US Paper Mill LLC Chillicothe, OH, US
3042765418 VITAL EDGE INSTRUMENTS LLC Leesburg, VA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003199637. Last updated year: 2026. Please use registration number 3003199637 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.