MULTISAFE SDN BHD

FDA Device Registration & Listing · BIDOR Perak, MY · Registration 9615095

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
9615095
FEI Number
3004360380
Entity Name
MULTISAFE SDN BHD
City/State/Country
BIDOR Perak, MY
Establishment Address
LOT 764, BIDOR INDUSTRIAL ESTATE, BIDOR Perak 35500, MY
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
MULTISAFE SDN BHD (Owner Number: 9039578)
Owner / Operator Contact Address
LOT 764, BIDOR INDUSTRIAL ESTATE, BIDOR, MY-08 35500, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K000999
PMA Number
N/A

All Registered Proprietary Names

CARBON VARIOUS MULTISAFE MULTISAFE MULTIPLE MULTISAFE CRANBERRY MULTIPLE

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 2018-11-13
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-12-31
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-12-31
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-12-31
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-25
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-12-31
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-12-31
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-12-31

Official Correspondent

NOR SURIA BINTI JOHAN

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

MULTISAFE 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 9615095. Last updated year: 2026. Please use registration number 9615095 when referencing this establishment in official correspondence.
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