Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027157158

FEI Number

3027157158

Entity Name

INEO TECH SDN BHD

City/State/Country

Bandar Cassia Pulau Pinang, MY

Establishment Address

PT5825, Jalan Cassia Selatan 3/11, Taman Perindustrian Batu Kawan,, Bandar Cassia Pulau Pinang 14110, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INEO TECH SDN BHD (Owner Number: 10087790)

Owner / Operator Contact Address

PT5825, Jalan Cassia Selatan 3/11, Taman Perindustrian Batu Kawan,, Bandar Cassia, MY-07 14110, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231973

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2023-04-10
OPH	Radiation Attenuating Medical Glove	General Hospital	Class 1	880.6250	2024-11-04
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

INEO TECH SDN BHD

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
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02

Similar Registrations

Registration Number	Establishment Name	Location
3014437893	NINGBO CHIBANDA IMP &EXP CO, LTD	Ningbo Zhejiang, CN
8043736	ANSELL N.P. SDN. BHD.	MELAKA, MY
2124215	Boston Scientific Corporation	Saint Paul, MN, US
3015378469	PUJIANG JIANYU SANITARY PRODUCTS COMPANY LTD.	Jinhua Zhejiang, CN
3012309743	Yiwu Ori-Power Medtech Co., Ltd.	YIWU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027157158. Last updated year: 2026. Please use registration number 3027157158 when referencing this establishment in official correspondence.