Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003699698

FEI Number

3003699698

Entity Name

MAXTER GLOVE MANUFACTURING SDN BHD

City/State/Country

KLANG Selangor, MY

Establishment Address

LOT 6070, JALAN HAJI ABDUL MANAN,, 6TH MILES OFF JALAN MERU, KLANG Selangor 41050, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAXTER GLOVE MANUFACTURING SDN BHD (Owner Number: 9048135)

Owner / Operator Contact Address

LOT 6070,JALAN HAJI ABDUL, MANAN, 6TH MILES OFF JALAN, MERU, KLANG, SELANGOR, MY-NOTA 41050, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113100

PMA Number

N/A

All Registered Proprietary Names

Maxter MAXTER MAXTER AURELIA MAXTER Maxter Maxter

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	2007-12-04
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-10-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-06-04
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2018-05-03
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-03-12
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2012-03-12

Official Correspondent

STANLEY THAI

US Agent Details

C.K. TAN Business: SUPERMAX HEALTHCARE, INC. Email: cktan@supermax-inc.com Phone: (630) 8988886

Related Public Records

Same Entity

MAXTER GLOVE MANUFACTURING 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
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

Similar Registrations

Registration Number	Establishment Name	Location
3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
1000266564	SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.	Hat Yai Songkhla, TH
8040653	ARISTA LATINDO INDUSTRIAL, LTD. P.T.	JAKARTA BARAT, ID
3002661124	ULINE, INC.	Pleasant Prairie, WI, US
3019769825	HARTALEGA NGC SDN. BHD. (LOT 39496)	Sepang Selangor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003699698. Last updated year: 2026. Please use registration number 3003699698 when referencing this establishment in official correspondence.