KL-KEPONG RUBBER PRODUCTS SDN. BHD.

FDA Device Registration & Listing · IPOH Perak, MY · Registration 3018167658

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
3018167658
FEI Number
3018167658
Entity Name
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
City/State/Country
IPOH Perak, MY
Establishment Address
Lot 134905, 3/4 Mile Off Jalan Bercham, Kawasan Perindustrian Bercham, IPOH Perak 31400, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
KL-Kepong Rubber Products Sdn. Bhd. (Owner Number: 10081041)
Owner / Operator Contact Address
Lot 134905, 3/4 Mile Off Jalan Bercham, Kawasan Perindustrian Bercham, IPOH, MY-08 31400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
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 2025-08-22
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-08-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-08-22
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-08-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-07-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-07-18

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

KL-Kepong Rubber Products 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 3018167658. Last updated year: 2026. Please use registration number 3018167658 when referencing this establishment in official correspondence.
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