GX Corporation Sdn Bhd (Specialty Plant)

FDA Device Registration & Listing · Klang Selangor, MY · Registration 3012441043

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
3012441043
FEI Number
3012441043
Entity Name
GX Corporation Sdn Bhd (Specialty Plant)
City/State/Country
Klang Selangor, MY
Establishment Address
Plot 6497-A, Lorong Haji Abdul Manan, 5 3/4 Milestone, Sementa. Jalan kapar,, Klang Selangor 42100, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GX CORPORATION SDN BHD (Owner Number: 9095340)
Owner / Operator Contact Address
Lot 6491, Batu 5 3/4 Sementa, Jalan Kapar, Klang, MY-10 42100, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K091151
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
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-11-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-03-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2007-11-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2010-11-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-11-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-11-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-08-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-02-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-04-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-07-06
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2019-07-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-12-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-09-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2007-02-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-06-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-11-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-12-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-08-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2010-02-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-06-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-06-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-06-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-06-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-06-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-06-30
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2019-06-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-06-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-06-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2007-11-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-06-11

Official Correspondent

No official correspondent registered.

US Agent Details

Danny West Business: FDA Agent Pro LLC Email: dwest@fdaagentpro.com Phone: (619) 4103883

Related Public Records

Same Entity

GX CORPORATION 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012441043. Last updated year: 2026. Please use registration number 3012441043 when referencing this establishment in official correspondence.
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