Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032579548

FEI Number

3032579548

Entity Name

INNOVARXI LTD.

City/State/Country

Concord Ontario, CA

Establishment Address

237 Romina Drive, Unit 4, Concord Ontario L4K 4V3, CA

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

INNOVARXI LTD. (Owner Number: 10091365)

Owner / Operator Contact Address

237 Romina Drive, Unit 4, Concord, CA-ON L4K 4V3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polymer Patient Examination glove Mask, Oxygen, Non-Rebreathing

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	2025-01-30
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2024-09-06

Official Correspondent

Walter Ramdeholl

US Agent Details

Carlos Ortiz Business: C ortiz independent consultant LLC Email: ortiz.carlos.a@hotmail.com Phone: (770) 7133630

Related Public Records

Same Entity

INNOVARXI LTD.

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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3043739177	US Paper Mill LLC	Chillicothe, OH, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032579548. Last updated year: 2026. Please use registration number 3032579548 when referencing this establishment in official correspondence.