MAH SING HEALTHCARE SDN BHD

FDA Device Registration & Listing · Klang Selangor, MY · Registration 3017887964

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
3017887964
FEI Number
3017887964
Entity Name
MAH SING HEALTHCARE SDN BHD
City/State/Country
Klang Selangor, MY
Establishment Address
Lot 6478, Lorong Sungai Puloh/ KU6, Kawasan Industri Sungai Puloh, Klang Selangor 42100, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Mah Sing Healthcare Sdn Bhd (Owner Number: 10079327)
Owner / Operator Contact Address
Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, Klang, MY-10 42100, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230002
PMA Number
N/A

All Registered Proprietary Names

Nitrile Powder Free Blue Examination Gloves, Non-Sterile Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs Nitrile Powder Free Black Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

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 2022-09-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-09-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-09-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-09
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-05-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-05-09

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

Mah Sing Healthcare 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 3017887964. Last updated year: 2026. Please use registration number 3017887964 when referencing this establishment in official correspondence.
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