Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8041150

FEI Number

3000239897

Entity Name

P.T. MAJA AGUNG LATEXINDO

City/State/Country

SUNGGAL DELI SERDANG Sumatera Utara, ID

Establishment Address

JL.UTAMA NO.98 PUJI MULIO, SUNGGAL DELI SERDANG Sumatera Utara 20352, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

P.T. MAJA AGUNG LATEXINDO (Owner Number: 8041150)

Owner / Operator Contact Address

JL. UTAMA NO. 98 PUJIMULIO, SUNGGAL DELI SERDANG, SUMATERA UTARA, ID-SU 20352, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K982897

PMA Number

N/A

All Registered Proprietary Names

Shamrock Shamrock Private brands Shamrock Polysilk

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	2007-12-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-08-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-12-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-06

Official Correspondent

JANE LAURENCE

US Agent Details

Louis Laurence Email: louis@smcgloves.com Phone: (909) 5918855

Related Public Records

Same Entity

P.T. MAJA AGUNG LATEXINDO

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

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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 8041150. Last updated year: 2026. Please use registration number 8041150 when referencing this establishment in official correspondence.