Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021233711

FEI Number

3021233711

Entity Name

AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.)

City/State/Country

SUNGAI PETANI Kedah, MY

Establishment Address

LOT 97, JALAN 10,, KAWASAN PERUSAHAAN BAKAR ARANG,, SUNGAI PETANI Kedah 08000, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AIMAX HEALTHCARE SDN. BHD. (Owner Number: 10083806)

Owner / Operator Contact Address

LOT 97, JALAN 10, KAWASAN PERUSAHAAN BAKAR ARANG, SUNGAI PETANI, MY-02 08000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221164

PMA Number

N/A

All Registered Proprietary Names

Powder Free Nitrile Examination Glove - Blue, Non Sterile Powder Free Nitrile Examination Glove - Black, Non-Sterile Powder Free Nitrile Examination Glove - White, Non-Sterile Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl

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	2021-12-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-01-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-12-21
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2022-08-31
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-08-31
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-08-31
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2022-08-31

Official Correspondent

MAGESH RAMANADAN

US Agent Details

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

Related Public Records

Same Entity

AIMAX HEALTHCARE 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

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
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
3042765418	VITAL EDGE INSTRUMENTS LLC	Leesburg, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021233711. Last updated year: 2026. Please use registration number 3021233711 when referencing this establishment in official correspondence.