Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042956952

FEI Number

3042956952

Entity Name

PROFESSIONAL LATEX SDN. BHD.

City/State/Country

KAMUNTING Perak, MY

Establishment Address

LOT 14202, JALAN PERUSAHAAN 3,, KAWASAN PERUSAHAAN KAMUNTING, KAMUNTING Perak 34600, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Professional Latex Sdn Bhd (Owner Number: 10055058)

Owner / Operator Contact Address

Lot 52, Jalan Logam 2, Kamunting Raya, Kamunting, MY-08 34600, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220088

PMA Number

N/A

All Registered Proprietary Names

Powder Free Nitrile Examination Glove Powder Free Latex Examination Glove LZC - Medical Glove, Specialty LZA - Polymer patient examination glove QDO - Fentanyl and other opioid protection glove OPJ - Medical gloves with chemotherapy labeling claims - test 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	2017-10-23
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2018-07-26
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-09-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-09-27
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-09-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-09-27

Official Correspondent

Yoon Lim kok

US Agent Details

YONG SUN Business: EMERGO GLOBAL REPRESENTATION LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Professional Latex 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
3012924721	PROFESSIONAL LATEX SDN BHD	Kamunting Perak, MY
3019585047	PROFESSIONAL LATEX SDN BHD	Kamunting Perak, 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

Similar Registrations

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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 3042956952. Last updated year: 2026. Please use registration number 3042956952 when referencing this establishment in official correspondence.