Arista Latindo Industrial, Ltd. P.T.
JAKARTA BARAT Jakarta, ID
ARISTA LATINDO INDUSTRIAL, LTD. P.T. appears in FDA device records in JAKARTA BARAT Jakarta, ID. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Arista Latindo Industrial, Ltd. P.T. between 1989 and 2004. The busiest year on record is 2003, with 6. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1993 | 2 |
| 1994 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 6 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041745 | VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR | LYZ | Substantially Equivalent | |
| K031944 | VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR | LZA | Substantially Equivalent | |
| K031913 | VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR | LYZ | Substantially Equivalent | |
| K030245 | NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR | LZA | Substantially Equivalent | |
| K023754 | VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E | LYZ | Substantially Equivalent | |
| K023753 | VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E | LYZ | Substantially Equivalent | |
| K023072 | POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR | LZA | Substantially Equivalent | |
| K022987 | LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | LYY | Substantially Equivalent | |
| K021412 | LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED | LYY | Substantially Equivalent | |
| K013320 | BLUE LATEX EXAMINATION GLOVES, POWDER FREE | LYY | Substantially Equivalent | |
| K002745 | VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR | LYZ | Substantially Equivalent | |
| K002746 | VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR | LYZ | Substantially Equivalent | |
| K991686 | LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) | LYY | Substantially Equivalent | |
| K971356 | POWDER FREE SYNTHETIC EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K954153 | ARISTA VINYL EXAMINATION GLOVES | LYZ | Substantially Equivalent | |
| K943707 | LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K934536 | VINYL EXAMINATION GLOVES (NON STERILE) | LYZ | Substantially Equivalent | |
| K921389 | POWDERFREE NATURAL LATEX GLOVES | LYY | Substantially Equivalent | |
| K925683 | NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) | LYY | Substantially Equivalent | |
| K896135 | STRAWBERRY SCENTED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K891441 | NON-STERILE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8040653 | 3002166545 | ARISTA LATINDO INDUSTRIAL, LTD. P.T. | Jl. K H Moh Mansyur No. 128, JAKARTA BARAT 11210 ID | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain