Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8041003

FEI Number

3009157666

Entity Name

LATEXX MANUFACTURING SDN. BHD.

City/State/Country

TAIPING Perak, MY

Establishment Address

LOT 18374, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE, TAIPING Perak 34600, MY

Establishment Type(s)

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

Owner / Operator

Latexx Manufacturing Sdn. Bhd. (Owner Number: 8041003)

Owner / Operator Contact Address

LOT 18374, JALAN PERUSAHAAN 3,, KAMUNTING INDUSTRIAL ESTATE, TAIPING, MY-08 34600, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051378

PMA Number

N/A

All Registered Proprietary Names

Starmed Ultra Nitrile Starmed Ultra Fresen Patient examination glove, specialty Black Colour Powder-Free Nitrile Rubber Examination Gloves Powdered Latex Examination Gloves Polymer patient examination glove Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves Polymer patient examination glove StarMed Plus Surgeon's gloves Nitrile Cornflower Blue Powder-Free Exam Tested for Use with Chemotherapy Drugs (Non-Sterile) Patient Examination Gloves (Latex) Semperguard Xpert Sempermed Safe Semperguard Force+ Surgeon's gloves Latex patient examination glove Latex Examination Powder-Free Gloves Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves Nitrile SPK-035VB NBR PF VB 6pc SP (Sample Gloves) StarMed Select NBR PF VB 100pc StarMed Plus NBR PF VB 300pc Tender Touch NBR PF VB 100pc M SemperForce Blue Nitrile NBR PF OB 100pc Nitrile Exam 200 NBR PF VB 200pc (IMCO) Nitrile SPK-030VB NBR PF VB 6pc SP (Sample Gloves) semperguard force blue Nitrile Exam NBR PF OB (IMCO) Tender Touch NBR PF VB 200pc StarMed Ultra Nitrile NBR PF VB 250pc semperguard Xpert Latex patient examination glove Polymer patient 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	2017-11-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-11-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-01-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-07
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2015-09-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-05
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-01-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-09-10
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-07
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-02-26
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-02-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-02-26
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-01-05
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-05
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2015-09-16
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-02-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-02-27
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-02-27
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-02-27
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-05

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

Latexx Manufacturing 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8041003. Last updated year: 2026. Please use registration number 8041003 when referencing this establishment in official correspondence.