Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006552561

FEI Number

3006552561

Entity Name

WEAR SAFE (MALAYSIA) SDN. BHD.

City/State/Country

KLANG Selangor, MY

Establishment Address

LOT 13726,JALAN HAJI SALLEH, BATU 5 1/4, OFF JALAN MERU, KLANG Selangor 41050, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WEAR SAFE (MALAYSIA) SDN BHD (Owner Number: 9066807)

Owner / Operator Contact Address

LOT 13726,JALAN HAJI SALLEH, BATU 5 1/4,, OFF JALAN MERU, KLANG, SELANGOR, 41050,, KLANG, MY-10 41050, MY

Initial Importer Flag

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
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-08-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-08-24
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-08-24
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-08-24
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2014-10-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-10-23
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2009-04-09
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2015-06-15
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2009-05-20
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2015-05-20
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-04-25
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2009-02-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2012-09-26
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-06-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2012-10-15

Official Correspondent

No official correspondent registered.

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

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010602489	WEAR SAFE (MALAYSIA) SDN BHD	KLANG Selangor, MY

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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3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US
3036774599	PT NEWPOINT TECHNOLOGY	Simalungun Sumatera Utara, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006552561. Last updated year: 2026. Please use registration number 3006552561 when referencing this establishment in official correspondence.