GP LUMUT

FDA Device Registration & Listing · Sitiawan Perak, MY · Registration 3011189071

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
3011189071
FEI Number
3011189071
Entity Name
GP LUMUT
City/State/Country
Sitiawan Perak, MY
Establishment Address
Lot No. 15652, Kawasan Perindustrian, Kampung Acheh, Sitiawan Perak 32000, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
GP Lumut (Owner Number: 10047087)
Owner / Operator Contact Address
Lot No. 15652, Kawasan Perindustrian, Kampung Acheh, Sitiawan, MY-08 32000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Purple 9.5 Benco dental

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 2021-08-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-08-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-08-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-08-09
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-08-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-08-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-09-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-09-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-11-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-04-20
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-08-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-08-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2014-12-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-11-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-11-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-01-07
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-01-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-01-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-07-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-07-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-07-25
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-07-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-12-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2014-12-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-12-18
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-12-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-12-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-12-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-10-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-06-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-10-19
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-01-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-01-25

Official Correspondent

Punitha Samy

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

GP Lumut
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 3011189071. Last updated year: 2026. Please use registration number 3011189071 when referencing this establishment in official correspondence.
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