Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004553390

FEI Number

3004553390

Entity Name

PERUSAHAAN GETAH ASAS SDN. BHD.

City/State/Country

JERAM Selangor, MY

Establishment Address

LOT 1365, BATU 17, JALAN SUNGAI SEMBILANG, JERAM Selangor 45800, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PERUSAHAAN GETAH ASAS SDN BHD (Owner Number: 8040956)

Owner / Operator Contact Address

LOT 1365, BATU 17, JALAN SUNGAI SEMBILANG, --, JERAM, MY-10 45800, MY

Initial Importer Flag

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
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2023-09-27
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2019-10-11
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-10-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-10-11
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2012-10-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-10-24
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2007-11-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-07-01
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2025-12-08
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-09-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-09-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2011-02-08
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2015-02-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-06-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-01
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-09-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-10-11
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-10-11
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2019-10-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-12
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-02-12
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2019-02-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-08-21
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-08-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-06-28
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2010-12-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-06-14

Official Correspondent

No official correspondent registered.

US Agent Details

Avani Patel Business: Parexel International Email: Avani.Patel@parexel.com Phone: (978) 4358575

Related Public Records

Same Entity

PERUSAHAAN GETAH ASAS 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
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
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07
K892946	Yeou-Fwu Rubber Industrial Co., Ltd.	STERILE PATIENT EXAMINATION GLOVES	1989-08-10

Similar Registrations

Registration Number	Establishment Name	Location
3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
1000266564	SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.	Hat Yai Songkhla, TH
8040653	ARISTA LATINDO INDUSTRIAL, LTD. P.T.	JAKARTA BARAT, ID
3002661124	ULINE, INC.	Pleasant Prairie, WI, US
3019769825	HARTALEGA NGC SDN. BHD. (LOT 39496)	Sepang Selangor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004553390. Last updated year: 2026. Please use registration number 3004553390 when referencing this establishment in official correspondence.