Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003529075

FEI Number

3003529075

Entity Name

PRIMUS GLOVES PRIVATE LTD.

City/State/Country

KAKKANAD, COCHIN, KERALA, IN

Establishment Address

14-A, COCHIN SPECIAL ECONOMIC, ZONE, KAKKANAD, COCHIN, KERALA 682037, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

PRIMUS GLOVES PRIVATE LIMITED (Owner Number: 9039301)

Owner / Operator Contact Address

14-A, COCHIN SPECIAL ECONOMIC ZONE,, KAKKANAD, COCHIN, IN-KL 682037, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001232

PMA Number

N/A

All Registered Proprietary Names

DYNAREX DYNAREX INVAGEN DYNAREX DYNAREX DYNAREX DYNAREX SHIELD LINE DYNAREX DYNAREX DYNAREX RAIVANSA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2018-11-16
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	2017-09-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-11-28
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-28
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-28
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-11-28
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2018-11-16
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-28
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-28

Official Correspondent

MINI MATHAI

US Agent Details

MANOJ ZACHARIAS Business: LIBERTY MANAGEMENT GROUP LTD Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

PRIMUS GLOVES PRIVATE LIMITED

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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003529075. Last updated year: 2026. Please use registration number 3003529075 when referencing this establishment in official correspondence.