KOON SENG SDN BHD

FDA Device Registration & Listing · Tangkak Johor, MY · Registration 3008509176

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
3008509176
FEI Number
3008509176
Entity Name
KOON SENG SDN BHD
City/State/Country
Tangkak Johor, MY
Establishment Address
PTD16058, Kawasan Perindustrian Tangkak, Jalan Muar, Tangkak Johor 84900, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KOON SENG SDN.BHD (Owner Number: 8040793)
Owner / Operator Contact Address
PTD 16058, KAWASAN PERINDUSTRIAN TANGKAK, JALAN MUAR, TANGKAK, MY-01 84900, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K013537
PMA Number
N/A

All Registered Proprietary Names

Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims ROYAL IMEPRIAL Powdered Latex Examination Gloves with Protein Control Labeling Claim (200 Micrograms or Less)

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 2011-07-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-16
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2021-12-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-12-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-12-28
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-12-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-07-10
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-07-10
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-07-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-07-10
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-10-18
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-10-20

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

KOON SENG 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 3008509176. Last updated year: 2026. Please use registration number 3008509176 when referencing this establishment in official correspondence.
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