IDEAL QUALITY SDN BHD

FDA Device Registration & Listing · KLANG Selangor, MY · Registration 3015335034

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015335034
FEI Number
3015335034
Entity Name
IDEAL QUALITY SDN BHD
City/State/Country
KLANG Selangor, MY
Establishment Address
LOT 6103, JALAN HAJI ABDUL MANAN / KU 8, KAWASAN PERINDUSTRIAN MERU SELATAN,, 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
N
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 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 2023-05-09
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-05-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-09
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-05-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2026-06-18
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2026-06-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-03-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-03-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-03-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-03-22
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-03-22

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
3013546437 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015335034. Last updated year: 2026. Please use registration number 3015335034 when referencing this establishment in official correspondence.
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