Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680710

FEI Number

3002808252

Entity Name

SUPERMAX GLOVE MANUFACTURING SDN BHD

City/State/Country

SUNGAI BULOH Selangor, MY

Establishment Address

LOT 38 & 42, PUTRA INDUSTRIAL PARK, BUKIT RAHMAN PUTRA, SUNGAI BULOH Selangor 47000, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUPERMAX GLOVE MANUFACTURING SDN BHD. (Owner Number: 9010828)

Owner / Operator Contact Address

LOT 38 & 42, PUTRA INDUSTRIAL PARK, BUKIT RAHMAN PUTRA, SUNGAI BULOH, SELANGOR, MY-NOTA 47000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993258

PMA Number

N/A

All Registered Proprietary Names

Supermax Supergloves King Medic Dent Aurelia Fantastik Supermax Fantastik Aurelia Supergloves Medic Dent King Supermax King Fantastik Supergloves Medic Dent Aurelia Supermax Medic Dent King Fantastik Supergloves Aurelia Supermax Aurelia Medic Dent Fantastik Supergloves King Supermax Medic Dent King Supergloves Aurelia Fantastik Supermax Fantastik Supergloves King Medic Dent Aurelia Supermax King Supergloves Medic Dent Aurelia Fantastik MEDIC DENT SUPERMAX KING FANTASTIK HIGH-MAX AURELIA SUPERGLOVES Fantastik Supergloves Medic Dent King Aurelia Supermax Supermax King Fantastik Supergloves Medic Dent Aurelia

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	2007-12-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2008-02-13
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-09-12
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-03-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-04
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-04
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-04
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-10-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2008-02-13

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

SUPERMAX GLOVE MANUFACTURING 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
3035455506	MAXTER HEALTHCARE PTE LTD	Singapore Central Singapore, SG

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

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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 9680710. Last updated year: 2026. Please use registration number 9680710 when referencing this establishment in official correspondence.