NEW ERA MEDICARE SDN BHD

FDA Device Registration & Listing · Teluk Intan Perak, MY · Registration 3021591322

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
3021591322
FEI Number
3021591322
Entity Name
NEW ERA MEDICARE SDN BHD
City/State/Country
Teluk Intan Perak, MY
Establishment Address
PT 2621-2624, Batu 8, Jalan Changkat Jong, Teluk Intan Perak 36000, MY
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
New Era Medicare Sdn Bhd (Owner Number: 10084255)
Owner / Operator Contact Address
PT 2621-2624, Batu 8, Jalan Changkat Jong, Teluk Intan, MY-08 36000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211022
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 2022-01-31
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-02-26
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-02-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-02-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-02-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-02-26
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-02-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-02-26

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

New Era 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 3021591322. Last updated year: 2026. Please use registration number 3021591322 when referencing this establishment in official correspondence.
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