Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016413634

FEI Number

3016413634

Entity Name

ECO MEDI GLOVE SDN BHD

City/State/Country

Taiping Perak, MY

Establishment Address

Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya, Taiping Perak 34600, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Eco Medi Glove Sdn Bhd (Owner Number: 10061572)

Owner / Operator Contact Address

Lot 26910, Lorong Perusahaan 3/3, Kamunting Raya Industrial Estate, Kamunting Raya, Taiping, MY-08 34600, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202401

PMA Number

N/A

All Registered Proprietary Names

Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim

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	2019-10-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-10-30
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-05-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-05-03
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-03-07

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 →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021591319	ECO MEDI GLOVE SDN BHD	Taiping Perak, MY

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

Similar Registrations

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9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016413634. Last updated year: 2026. Please use registration number 3016413634 when referencing this establishment in official correspondence.