FDA Registration
Active
🇨🇦 Canada
Ansell Canada Inc.
Reg #: 3003199637
·
FEI: 3003199637
·
Expires 2026
Products
8
Proprietary Names
5
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Ansell Canada Inc.
- Registration Number
- 3003199637
- FEI Number
- 3003199637
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 105 Rue Lauder
- City
- Cowansville Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K083624
Owner / Operator
- Firm Name
- ANSELL HEALTHCARE PRODUCTS LLC
- Operator Number
- 8020065
- Address
- 2301 Robb Drive
- City
- Reno
- State
- NV
- Postal Code
- 89523
- Country
- US
- Correspondent
- Don Cronk
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2017-02-23 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2019-09-16 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2016-11-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2016-11-03 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2019-09-16 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-05-30 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2017-02-24 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2019-09-18 |
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
FISHER 19-041-171X
Establishment Types
Export Device to the United States But Perform No Other Operation on Device