ECO MEDI GLOVE SDN BHD

FDA Device Registration & Listing · Taiping Perak, MY · Registration 3010763223

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
3010763223
FEI Number
3010763223
Entity Name
ECO MEDI GLOVE SDN BHD
City/State/Country
Taiping Perak, MY
Establishment Address
Lot 23826,. Jalan Tembaga Kuning, Kawasan Perindustrian Kamunting Raya, Taiping Perak 34600, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ECO Medi Glove SDN BHD (Owner Number: 10047533)
Owner / Operator Contact Address
Lot 23826,Jalan Tembaga Kuning, Kawasan Perindustrian Kamunting Raya, Taiping, MY-08 34600, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233560
PMA Number
N/A

All Registered Proprietary Names

Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim EMG Blue Nitrile Examination Glove Powder Free with tested for used with Chemotherapy Drugs Powder Free Nitrile Examination Glove (Aqua Green) EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented Get-A-Grip Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim EMG Pink Nitrile Examination Glove Powder Free

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 2015-02-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-08-04
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-08-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-06-08
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-02-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-02-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-02-27
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-02-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-09-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-09-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-12-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-05-24
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-05-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-10-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-02-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-06-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-03-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-03-23
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-05-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-05-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-10-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2015-02-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-09-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-02-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-02-27
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-02-27
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

ECO Medi Glove 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 3010763223. Last updated year: 2026. Please use registration number 3010763223 when referencing this establishment in official correspondence.
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