PROFESSIONAL LATEX SDN BHD

FDA Device Registration & Listing · Kamunting Perak, MY · Registration 3012924721

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
3012924721
FEI Number
3012924721
Entity Name
PROFESSIONAL LATEX SDN BHD
City/State/Country
Kamunting Perak, MY
Establishment Address
Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 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
N
Expiration Date (Year)
2026
510(k) Number
K171667
PMA Number
N/A

All Registered Proprietary Names

ALLOGEL-BLUEMAX ALLOGEL-MAGENTA ALLOGEL Powder Free Latex Examination Glove ALLOGEL Powder Free Nitrile Examination Glove

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 2019-08-28
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2018-07-26
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2019-08-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-10-23

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
3042956952 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012924721. Last updated year: 2026. Please use registration number 3012924721 when referencing this establishment in official correspondence.
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