Central Medicare Sdn Bhd
Teluk Intan Perak, MY
CENTRAL MEDICARE SDN BHD appears in FDA device records in Teluk Intan Perak, MY. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Central Medicare Sdn Bhd between 2010 and 2023. The busiest year on record is 2023, with 4. The most recent is 2023, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230681 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | LZA | Substantially Equivalent | |
| K223752 | Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl | LZA | Substantially Equivalent | |
| K230875 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | LZA | Substantially Equivalent | |
| K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | LZA | Substantially Equivalent | |
| K213437 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | LZA | Substantially Equivalent | |
| K211022 | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. | LZA | Substantially Equivalent | |
| K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) | LZA | Substantially Equivalent | |
| K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | LZC | Substantially Equivalent | |
| K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | |
| K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | LZC | Substantially Equivalent | |
| K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | |
| K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) | LZA | Substantially Equivalent | |
| K113440 | HIGH FIVE | LZA | Substantially Equivalent | |
| K103734 | POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE | LZA | Substantially Equivalent | |
| K093696 | SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008253024 | 3008253024 | CENTRAL MEDICARE SDN BHD | Plot 2609-2620, Batu 8, Jalan Changkat Jong, Teluk Intan Perak 36000 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain