Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040653

FEI Number

3002166545

Entity Name

ARISTA LATINDO INDUSTRIAL, LTD. P.T.

City/State/Country

JAKARTA BARAT, ID

Establishment Address

Jl. K H Moh Mansyur No. 128, JAKARTA BARAT 11210, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARISTA LATINDO INDUSTRIAL, LTD. P.T. (Owner Number: 8040653)

Owner / Operator Contact Address

Jl. K H Moh Mansyur No. 128, JAKARTA 11210, ID-NOTA 11210, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K002746

PMA Number

N/A

All Registered Proprietary Names

Arista Nitrile Examination Gloves Arista Latex Examination Gloves Arista Vinyl Examination Gloves Arista Latex Examination Gloves Arista Latex Examination Gloves Arista Vinyl Examination Gloves Arista Nitrile Examination Gloves Arista Vinyl Examination Gloves Arista Latex Examination Gloves Arista Latex Examination Gloves Arista Latex Examination Gloves Arista Vinyl Examination Gloves Arista Nitrile Examination Gloves Arista Vinyl Examination Gloves Arista Latex Examination Gloves Arista Vinyl Examination Gloves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2008-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

Chairina Breder Business: Genlee Corporation Email: chairina@hotmail.com Phone: (650) 6975831

Related Public Records

Same Entity

ARISTA LATINDO INDUSTRIAL, LTD. P.T.

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
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040653. Last updated year: 2026. Please use registration number 8040653 when referencing this establishment in official correspondence.