Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045079147

FEI Number

3045079147

Entity Name

12496925 CANADA INC.

City/State/Country

Oakville Ontario, CA

Establishment Address

2844 Bristol Circle, Oakville Ontario L6H 6G4, CA

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

12496925 Canada Inc. (Owner Number: 10095753)

Owner / Operator Contact Address

2844 Bristol Circle, Oakville, CA-ON L6H 6G4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SKY Nitrile Examination Gloves SKY Powder-Free Clear Vinyl Patient Examination Gloves

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	2026-04-23
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-04-23
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2026-04-23

Official Correspondent

Bryan Holden

US Agent Details

Abul Ansari Business: Arora 297 Consultancy LLC Email: aqansari31@gmail.com Phone: (603) 2030935

Related Public Records

Same Entity

12496925 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

Similar Registrations

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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 3045079147. Last updated year: 2026. Please use registration number 3045079147 when referencing this establishment in official correspondence.