TG WORLDWIDE SDN. BHD.

FDA Device Registration & Listing · Shah Alam Selangor, MY · Registration 3020521811

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
3020521811
FEI Number
3020521811
Entity Name
TG WORLDWIDE SDN. BHD.
City/State/Country
Shah Alam Selangor, MY
Establishment Address
16 Persiaran Setia Dagang, Shah Alam Selangor 40170, MY
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
TG WORLDWIDE SDN. BHD. (Owner Number: 10082693)
Owner / Operator Contact Address
16 Persiaran Setia Dagang, Shah Alam, MY-10 40170, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K990668
PMA Number
N/A

All Registered Proprietary Names

PATIENT EXAMINATION GLOVE SURGEON GLOVE POLYMER PATIENT EXAMINATION GLOVE PATIENT EXAMINATION GLOVE PATIENT EXAMINATION GLOVE POLYMER PATIENT EXAMINATION GLOVE PATIENT EXAMINATION GLOVE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-12-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-12-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-05-15
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-05-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-05-15
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-05-15
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-12-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-09-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-03-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-03-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-12-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2021-12-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-12-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-09-09
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-09-09
EIE Dam, Rubber Dental Class 1 872.6300 2021-12-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-09-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-09
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-02-15
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-02-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-02-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-02-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-09
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2021-12-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-12-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-12-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-09

Official Correspondent

Yong Lin Ng

US Agent Details

DAVID LIM Business: TG MEDICAL (USA), INC Email: limdavid33@gmail.com Phone: (626) 9697838

Related Public Records

Same Entity

TG WORLDWIDE 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 3020521811. Last updated year: 2026. Please use registration number 3020521811 when referencing this establishment in official correspondence.
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