GRAND TEN HOLDINGS SDN BHD

FDA Device Registration & Listing · Sepang Selangor, MY · Registration 3010966951

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
3010966951
FEI Number
3010966951
Entity Name
GRAND TEN HOLDINGS SDN BHD
City/State/Country
Sepang Selangor, MY
Establishment Address
Plot PT5754, Jalan 2, Kawasan, Perusahaan Bandar Baru Salak Tinggi, Sepang Selangor 43900, MY
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
GRAND TEN HOLDINGS SDN BHD (Owner Number: 10046980)
Owner / Operator Contact Address
Plot PT5754, Jalan 2, Kawasan, Perusahaan Bandar Baru Salak Tinggi, Sepang, MY-10 43900, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
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
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2014-06-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2014-06-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2014-06-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2014-06-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2014-06-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

GRAND TEN HOLDINGS 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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8041005 WRP ASIA PACIFIC SDN. BHD. SALAK TINGGI, SEPANG Selangor, MY
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010966951. Last updated year: 2026. Please use registration number 3010966951 when referencing this establishment in official correspondence.
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