Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613998

FEI Number

3006581410

Entity Name

GALLANT QUALITY SDN. BHD.

City/State/Country

TAIPING, PERAK, MY

Establishment Address

LOT 1874, JALAN KAMPUNG DEW, TAIPING, PERAK 34700, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GALLANT QUALITY SDN BHD (Owner Number: 9103901)

Owner / Operator Contact Address

LOT 1874, JALAN KAMPUNG DEW, --, TAIPING, PERAK, MY-NOTA 34700, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Olivia Claire Health Nitrile Examination Gloves Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Powder Free Nitrile (Orange) Examination Gloves Powder Free Nitrile (Black) Examination Gloves VGUARD Nitrile PF Exam NITRILE EXAMINATION GLOVES PATIENT PF LATEX EXAMINATION GLOVES Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Labeling Claim Green

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2018-06-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-06-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2011-01-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-01-11
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2022-01-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-01-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-03-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-06-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2015-12-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2009-01-12
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	1998-03-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-06-04
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-06-04

Official Correspondent

LEONG CHOI LING

US Agent Details

TERRELL CUNNINGHAM Business: T. Cunningham Consulting & Associates, LLC Email: cunninghamterrella@gmail.com Phone: (301) 5359600

Related Public Records

Same Entity

GALLANT QUALITY 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
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

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613998. Last updated year: 2026. Please use registration number 9613998 when referencing this establishment in official correspondence.