Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040980

FEI Number

3166

Entity Name

KANAM LATEX INDUSTRIES PVT. LTD.

City/State/Country

NAGERCOIL Tamil Nadu, IN

Establishment Address

3/13F,WEST PERUVILAI RD., PERUVILAI RD.,, NAGERCOIL Tamil Nadu 629 003, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KANAM LATEX INDUSTRIES PVT. LTD. (Owner Number: 8040980)

Owner / Operator Contact Address

OOPPOOTTIL BUILDINGS, K.K. RD., --, KOTTAYAM, KERALA, IN-NOTA 686 001, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K904972

PMA Number

N/A

All Registered Proprietary Names

KALTEX KALTEX SURGICARE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-03
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-03
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Reiber Business: Innovative Healthcare Corp Email: mreiber@ihcsolutions.com Phone: (918) 2458400

Related Public Records

Same Entity

KANAM LATEX INDUSTRIES PVT. LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004967282	KANAM LATEX INDUSTRIES PVT. LTD.	NAGERCOIL Tamil Nadu, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07
K892946	Yeou-Fwu Rubber Industrial Co., Ltd.	STERILE PATIENT EXAMINATION GLOVES	1989-08-10

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3002661124	ULINE, INC.	Pleasant Prairie, WI, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040980. Last updated year: 2026. Please use registration number 8040980 when referencing this establishment in official correspondence.