TG MEDICAL SDN BHD

FDA Device Registration & Listing · KLANG Selangor, MY · Registration 9680622

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
9680622
FEI Number
3002808366
Entity Name
TG MEDICAL SDN BHD
City/State/Country
KLANG Selangor, MY
Establishment Address
LOT 5091, JALAN TERATAI, BT 5, OFF JALAN MERU, KLANG Selangor 41050, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
TG MEDICAL SDN BHD (Owner Number: 9010202)
Owner / Operator Contact Address
LOT 5091, JALAN TERATAI, BT 5,, OFF JALAN MERU, KLANG, MY-10 41050, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171276
PMA Number
N/A

All Registered Proprietary Names

Polymer Patient Examination Glove

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 2025-01-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-02
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-01-02
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2026-05-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2026-05-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2026-05-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2026-05-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-12-16
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2024-12-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-12-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-05-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-05-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-06-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-31
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-31
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-07-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-07-28
EIE Dam, Rubber Dental Class 1 872.6300 2025-12-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-12-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2012-09-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-06-20
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-11-16
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-11-16

Official Correspondent

LIM WEE-CHAI

US Agent Details

David Lim Email: Limdavid33@Gmail.com Phone: (626) 9697838

Related Public Records

Same Entity

TG MEDICAL 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 9680622. Last updated year: 2026. Please use registration number 9680622 when referencing this establishment in official correspondence.
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