Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8041092

FEI Number

3002914051

Entity Name

PT. INTAN HEVEA INDUSTRY

City/State/Country

MEDAN Sumatera Utara, ID

Establishment Address

JL.PULAU IRIAN (KAWASAN INDUSTRY MEDAN), JL. KOM LAUT YOS SUDARSO KM 10.5, MEDAN Sumatera Utara 20242, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

PT. INTAN HEVEA INDUSTRY (Owner Number: 8041092)

Owner / Operator Contact Address

JALAN PULAU IRIAN NO.13, KAWASAN INDUSTRI MEDAN 1, MABAR, MEDAN, ID-SU 20371, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111923

PMA Number

N/A

All Registered Proprietary Names

UNISEAL Powder Free Latex Examination Gloves Blue Colored SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES,NON-STERILE

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	2016-04-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2012-01-03

Official Correspondent

MANSUR TANDJO

US Agent Details

KENMAYNARD KENMAYNARD Business: KEMCO SUPPLY Email: kemcoglove@aol.com Phone: (425) 3924803

Related Public Records

Same Entity

PT. INTAN HEVEA INDUSTRY

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 8041092. Last updated year: 2026. Please use registration number 8041092 when referencing this establishment in official correspondence.