Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680466

FEI Number

3006993432

Entity Name

HL RUBBER INDUSTRIES SDN BHD

City/State/Country

KUALA PILAH Negeri Sembilan, MY

Establishment Address

LOT 10, KAWASAN, PERINDUSTRIAN DIOH, KUALA PILAH Negeri Sembilan 72000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

HL RUBBER INDUSTRIES SDN BHD (Owner Number: 9090472)

Owner / Operator Contact Address

LOT 10, KAWASAN PERINDUSTRIAN, DIOH, KUALA PILAH, MY-05 72000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130038

PMA Number

N/A

All Registered Proprietary Names

Powder-Free Nitrile Examination Gloves, Blue with Mint Scented POWDERED PATIENT NITRILE EXAMINATION GLOVES (WHITE/BLUE COLOR) POWDER-FREE NITRILE POWDERED PATIENT NITRILE EXAMINATIO POWDER-FREE LATEX EXAMINATION GLOVES, NON-STERILE POWDERED LATEX PATIENT EXAMINATION N GLOVE POWDER-FREE PATIENT EXAMINATION GL Powder-Free Nitrile Examination Gloves, Orange Color POWDER-FREE NITRILE WHITE AND BLUE EXAMINATION GLOVES Olivia Claire Health POWDER-FREE NITRILE Powder Free Nitrile Gloves, Black Olivia Claire Health Black Magic Powder-Free Nitrile Examination Gloves, Blue, 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	2014-12-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-03-09
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2001-10-25
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-12-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-03-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2010-12-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2013-11-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-21

Official Correspondent

Chan Yoke Chun

US Agent Details

Elizabeth Deng Business: Elizabeth Deng Email: baxianunited48@yahoo.com Phone: (909) 4659188

Related Public Records

Same Entity

HL RUBBER INDUSTRIES 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

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3042765418	VITAL EDGE INSTRUMENTS LLC	Leesburg, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680466. Last updated year: 2026. Please use registration number 9680466 when referencing this establishment in official correspondence.