WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II

FDA Device Registration & Listing · Klang Selangor, MY · Registration 3010195579

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
3010195579
FEI Number
3010195579
Entity Name
WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II
City/State/Country
Klang Selangor, MY
Establishment Address
LOT 63616, PT 54924, NO 3, Jalan Korporat 7C/KU9, Taman Perindustrian Meru, Mukim Kapar,, Klang Selangor 42200, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II (Owner Number: 10043522)
Owner / Operator Contact Address
LOT 63616, PT 54924, NO 3, Jalan, Korporat 7C/KU9,Taman Perindustrian Meru, Mukim Kapar, Klang, MY-10 42200, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
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
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-09-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-09-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-10-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-10-10
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-07-23
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-11-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-11-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-11-30
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-11-30
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2019-06-24
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-06-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-06-24
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2019-06-10
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-06-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-06-10
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-02-25
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
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-05-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-09

Official Correspondent

LIM SIEW BING

US Agent Details

Avani Patel Business: Parexel International Email: Avani.Patel@parexel.com Phone: (978) 4358575

Related Public Records

Same Entity

WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II
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 3010195579. Last updated year: 2026. Please use registration number 3010195579 when referencing this establishment in official correspondence.
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