NITRILIST GLOVES MANUFACTURING SDN BHD

FDA Device Registration & Listing · KUALA PILAH, Negeri Sembilan, MY · Registration 3010811068

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
3010811068
FEI Number
3010811068
Entity Name
NITRILIST GLOVES MANUFACTURING SDN BHD
City/State/Country
KUALA PILAH, Negeri Sembilan, MY
Establishment Address
PT 197,KAWASAN PERINDUSTRIAN DIOH,, KUALA PILAH,, KUALA PILAH, Negeri Sembilan 72000, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nitrilist Gloves Manufacturing Sdn Bhd (Owner Number: 10046405)
Owner / Operator Contact Address
PT 197,KAWASAN PERINDUSTRIAN DIOH,, KUALA PILAH,, KUALA PILAH,, MY-05 72000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K122874
PMA Number
N/A

All Registered Proprietary Names

Nitrile Examination Gloves

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 2014-03-19

Official Correspondent

Wong Kok Wah

US Agent Details

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

Related Public Records

Same Entity

Nitrilist Gloves 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 3010811068. Last updated year: 2026. Please use registration number 3010811068 when referencing this establishment in official correspondence.
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