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Central Medicare Sdn Bhd: FDA-registered device maker in Teluk Intan Perak, Malaysia, 15 510(k) clearances

Name: Central Medicare Sdn Bhd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Central Medicare Sdn Bhd is registered with the FDA (registration 3008253024) in Teluk Intan Perak, Malaysia. It lists 6 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 2, 2023. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Central Medicare Sdn Bhd

FDA registration number: 3008253024
Address: Plot 2609-2620, Batu 8, Jalan Changkat Jong, Teluk Intan Perak, Malaysia, 36000
Owner or operator: Central Medicare Sdn Bhd (10028684)
Roles: Contract manufacturer, Manufacturer
First device listed: February 22, 2010
Registered through: 2027
Brand names listed: HALYARD* Purple Nitrile* Powder Free Exam Textured 9.5? Glove, Lavender Exam Gloves, Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black Colors), Orange Non Sterile Powder Free Nitrile Examination Gloves, Purple Nitrile Exam Glove

Devices it lists

Device	Product code	Class	Role	Source
Fentanyl And Other Opioid Protection Glove	QDO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Manufacturer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 2, 2023	K230681	Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl	LZA	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
July 24, 2023	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	Central Medicare Sdn Bhd	accessdata.fda.gov
July 20, 2023	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	Central Medicare Sdn Bhd	accessdata.fda.gov
May 23, 2023	K230564	Green Non Sterile Powder Free Nitrile Examination Gloves	LZA	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
January 26, 2023	K221424	Sterile Surgical Powder Free Latex Glove	KGO	Substantially Equivalent	New Era Medicare Sdn. Bhd.	accessdata.fda.gov
October 28, 2022	K221667	Non Sterile Powder Free Latex Examination Glove	LYY	Substantially Equivalent	New Era Medicare Sdn. Bhd.	accessdata.fda.gov
April 11, 2022	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	Central Medicare Sdn Bhd	accessdata.fda.gov
December 22, 2021	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	Central Medicare Sdn Bhd	accessdata.fda.gov
May 7, 2021	K203036	Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)	LZA	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
October 4, 2019	K183441	Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs	LZA	Substantially Equivalent	Semperit Investments Asia Pte , Ltd.	accessdata.fda.gov
July 4, 2019	K183149	Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim	LZC	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
March 5, 2018	K173942	Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs	LZC	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
November 28, 2017	K172642	Orange Non Sterile Powder Free Nitrile Examination Gloves	LZC	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
November 13, 2017	K172525	Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs	LZC	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
January 22, 2015	K143247	Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)	LZA	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov

Compare with other makers

Updated October 2, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.