Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013546437

FEI Number

3013546437

Entity Name

IDEAL QUALITY SDN BHD

City/State/Country

Klang Selangor, MY

Establishment Address

LOT 6075, JALAN HAJI ABDUL MANAN / KU 8, KAWASAN PERINDUSTRIAN MERU BARAT,, Klang Selangor 41050, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IDEAL QUALITY SDN BHD (Owner Number: 10030536)

Owner / Operator Contact Address

LOT 6075, JALAN HAJI ABDUL MANAN / KU8, KAWASAN PERINDUSTRIAN MERU BARAT, KLANG, MY-10 41050, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2026-02-05
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-02-05
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-02-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-02-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2011-09-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-09-13
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2011-05-05
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-12-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-11
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-12-11
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-12-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2011-03-28

Official Correspondent

KUANG YONG LIM

US Agent Details

Avani Patel Business: Parexel International Email: Avani.Patel@parexel.com Phone: (978) 4358575

Related Public Records

Same Entity

IDEAL QUALITY SDN BHD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015335034	IDEAL QUALITY SDN BHD	KLANG Selangor, MY

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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3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US
3036774599	PT NEWPOINT TECHNOLOGY	Simalungun Sumatera Utara, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013546437. Last updated year: 2026. Please use registration number 3013546437 when referencing this establishment in official correspondence.