ONETEXX SDN BHD

FDA Device Registration & Listing · Kamunting Perak, MY · Registration 3019252794

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
3019252794
FEI Number
3019252794
Entity Name
ONETEXX SDN BHD
City/State/Country
Kamunting Perak, MY
Establishment Address
No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3,, Kamunting Raya Industrial Park, Kamunting Perak 34600, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Onetexx Sdn Bhd (Owner Number: 10081868)
Owner / Operator Contact Address
No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3,, Kamunting Raya Industrial Park, Kamunting, MY-08 34600, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222298
PMA Number
N/A

All Registered Proprietary Names

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile Kenaflexx Nitrile Examination Gloves Powder Free Black Black Nitrile Powder Free Patient Examination Glove, Non Sterile White Nitrile Powder Free Patient Examination Glove, Non Sterile LYDUS Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fe

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 2021-05-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-06-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-01-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-07-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-01-04
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-10-14
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2022-10-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-10-14
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-10-14
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-08-06
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-08-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-08-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-08-06

Official Correspondent

Freddy Low

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Onetexx 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 3019252794. Last updated year: 2026. Please use registration number 3019252794 when referencing this establishment in official correspondence.
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