CENTRAL MEDICARE SDN BHD

FDA Device Registration & Listing · Teluk Intan Perak, MY · Registration 3008253024

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
3008253024
FEI Number
3008253024
Entity Name
CENTRAL MEDICARE SDN BHD
City/State/Country
Teluk Intan Perak, MY
Establishment Address
Plot 2609-2620, Batu 8, Jalan Changkat Jong, Teluk Intan Perak 36000, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Central Medicare Sdn Bhd (Owner Number: 10028684)
Owner / Operator Contact Address
Plot 2609-2620, Batu 8, Jalan Changkat Jong,, Teluk Intan, MY-08 36000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230564
PMA Number
N/A

All Registered Proprietary Names

HALYARD* Purple Nitrile* Powder Free Exam Textured 9.5? Glove Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black Colors) Lavender Exam Gloves Purple Nitrile Exam Glove

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 2018-11-16
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-03-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-03-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-08-02
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-08-02
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-08-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-08-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-02-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-01-26
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2023-08-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-01-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-01-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-11-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-05-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-10-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-10-13
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-11-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-11-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-11-15
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-11-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-09-01
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-09-01
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2021-09-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-08-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-12-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-12-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-08-04
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-08-04
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-08-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-10-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-01-22
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-01-22
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-08-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-08-16
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-08-16
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-02-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-12-26
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-12-26
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-12-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-12-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2010-02-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-01-08
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-01-08
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-01-08
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-08-21
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-08-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-08-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-08-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2023-08-21
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-07-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-07-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-07-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-07-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-12-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-12-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-12-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2011-08-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2012-05-29
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2019-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-07-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-08-21

Official Correspondent

Muhammad Abdul Rahman

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Central Medicare 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 3008253024. Last updated year: 2026. Please use registration number 3008253024 when referencing this establishment in official correspondence.
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