TOP GLOVE SDN. BHD.

FDA Device Registration & Listing · KLANG Selangor, MY · Registration 8043848

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
8043848
FEI Number
3003564842
Entity Name
TOP GLOVE SDN. BHD.
City/State/Country
KLANG Selangor, MY
Establishment Address
LOT 4969,JALAN TERATAI,BATU 6, OFF JALAN MERU, KLANG Selangor 41050, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TOP GLOVE SDN. BHD. (Owner Number: 9004187)
Owner / Operator Contact Address
LOT 4969, JALAN TERATAI, BATU 6, OFF JALAN MERU, KLANG, MY-10 41050, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K122999
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-11-16
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-11-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-09-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2012-12-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2012-12-06

Official Correspondent

TONG SIEW BEE

US Agent Details

David Lim Email: Limdavid33@Gmail.com Phone: (626) 9697838

Related Public Records

Same Entity

TOP GLOVE 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
K002933 Maxxim Medical STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES 2000-10-19
K913402 Smith & Nephew Perry PERRY(R) DERMAGUARD(R) PLUS GLOVES 1991-10-02
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043848. Last updated year: 2026. Please use registration number 8043848 when referencing this establishment in official correspondence.
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