WRP ASIA PACIFIC SDN. BHD.

FDA Device Registration & Listing · SALAK TINGGI, SEPANG Selangor, MY · Registration 8041005

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
8041005
FEI Number
3002808507
Entity Name
WRP ASIA PACIFIC SDN. BHD.
City/State/Country
SALAK TINGGI, SEPANG Selangor, MY
Establishment Address
LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU, SALAK TINGGI, SEPANG Selangor 43900, MY
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
WRP ASIA PACIFIC SDN. BHD. (Owner Number: 8041005)
Owner / Operator Contact Address
LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI, SEPANG, MY-10 43900, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K935866
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 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-08-13
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-01-15
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 1994-08-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-11-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-11-02
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-09-15
FMC Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-09-02
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-09-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-09-02
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-01-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2023-09-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-09-03
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-09-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-09-03
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-04-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
GBA Catheter, Balloon Type General, Plastic Surgery Class 1 878.4200 1989-03-15
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-07-01
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-01-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-11-03
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-11-03
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-11-03
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-11-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-01-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-04-17

Official Correspondent

Saravanan Ramasamy

US Agent Details

Michael Scaglione Business: SG Global, LLC Email: mjs@wrp-usa.com Phone: (330) 2840252

Related Public Records

Same Entity

WRP ASIA PACIFIC 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8041005. Last updated year: 2026. Please use registration number 8041005 when referencing this establishment in official correspondence.
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