TERANG NUSA (MALAYSIA) SDN. BHD.

FDA Device Registration & Listing · Kota Bharu Kelantan, MY · Registration 3012304897

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
3012304897
FEI Number
3012304897
Entity Name
TERANG NUSA (MALAYSIA) SDN. BHD.
City/State/Country
Kota Bharu Kelantan, MY
Establishment Address
2, Jalan 8, Pengkalan Chepa Industrial Zone 2, Kota Bharu Kelantan 16100, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Terang Nusa (Malaysia) Sdn. Bhd. (Owner Number: 10062210)
Owner / Operator Contact Address
2, Jalan 8, Pengkalan Chepa Industrial Zone 2, Kota Bharu, MY-03 16100, 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 2020-04-30
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-04-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-03-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-04-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-04-30
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-04-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-03-02
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-04-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-04-29
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-04-30
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-04-30

Official Correspondent

JAYSON LEE

US Agent Details

David Lim Email: limdavid33@gmail.com Phone: (626) 9697838

Related Public Records

Same Entity

Terang Nusa (Malaysia) 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
K894452 Kerala Rubber & Reclaims, Ltd. KRR GLOVE, PATIENT EXAMINATION GLOVES 1989-08-09
K891323 Li Wah-Hong Kong, Inc. LI WAH LATEX EXAMINATION GLOVES 1989-08-31
K891418 C & K Mfg. & Sales Co. LATEX EXAMINATION GLOVES, STYLE 510 LX 1989-06-22

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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 3012304897. Last updated year: 2026. Please use registration number 3012304897 when referencing this establishment in official correspondence.
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