Data / Medical devices / Malaysia / New Era Medicare Sdn Bhd
New Era Medicare Sdn Bhd: FDA-registered device maker in Teluk Intan Perak, Malaysia, 3 510(k) clearances
New Era Medicare Sdn Bhd is registered with the FDA (registration 3021591322) in Teluk Intan Perak, Malaysia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021591322
- Address
- PT 2621-2624, Batu 8 Jalan Changkat Jong, Teluk Intan Perak, Malaysia, 36000
- Owner or operator
- New Era Medicare Sdn Bhd (10084255)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 31, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 27, 2024 | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | 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 |
| November 8, 2019 | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | LZC | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
Updated September 27, 2024. 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.