AAMEDIX GLOVE SDN BHD

FDA Device Registration & Listing · Shah Alam Selangor, MY · Registration 3017207705

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
3017207705
FEI Number
3017207705
Entity Name
AAMEDIX GLOVE SDN BHD
City/State/Country
Shah Alam Selangor, MY
Establishment Address
Unit 19D, Level 19, No.16, Persiaran Setia Dagang, Bandar Setia Alam, 40170 Shah Alam, Selangor Darul Ehsan, Shah Alam Selangor 40170, MY
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
AAMedix Glove Sdn Bhd (Owner Number: 10084933)
Owner / Operator Contact Address
Unit 19D, Level 19, No. 16, Persiaran Setia Dagang, Bandar Setia Alam,, 40170 Shah Alam, Selangor Darul Ehsan, Malaysia, Shah Alam, MY-10 40170, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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 2022-04-16

Official Correspondent

ENG SOON KER

US Agent Details

Tim Thai Business: Mexpo International Inc. Email: tim@mexpo-glove.com Phone: (510) 4896800

Related Public Records

Same Entity

AAMedix 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 3017207705. Last updated year: 2026. Please use registration number 3017207705 when referencing this establishment in official correspondence.
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