Data / Medical devices / Indonesia / Arista Latindo Industrial, Ltd. P.T.
Arista Latindo Industrial, Ltd. P.T.: FDA-registered device maker in Jakarta Barat, Indonesia, 24 510(k) clearances
Arista Latindo Industrial, Ltd. P.T. is registered with the FDA (registration 8040653) in Jakarta Barat, Indonesia. It lists 3 device types. The FDA files 24 510(k) clearances under its listings, the newest dated July 15, 2004. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8040653
- FEI number
- 3002166545
- Address
- Jl. K H Moh Mansyur No. 128, Jakarta Barat, Indonesia, 11210
- Owner or operator
- ARISTA LATINDO INDUSTRIAL, LTD. P.T. (8040653)
- Roles
- Manufacturer
- First device listed
- January 11, 2008
- Registered through
- 2026
- Brand names listed
- Arista Latex Examination Gloves, Arista Nitrile Examination Gloves, Arista Vinyl Examination Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 15, 2004 | K041745 | VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| September 23, 2003 | K031944 | VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR | LZA | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| July 9, 2003 | K031913 | VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| April 4, 2003 | K030245 | NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR | LZA | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| March 25, 2003 | K023754 | VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| March 25, 2003 | K023753 | VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| February 13, 2003 | K023072 | POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR | LZA | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| October 21, 2002 | K022987 | LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| June 7, 2002 | K021412 | LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| December 19, 2001 | K013320 | BLUE LATEX EXAMINATION GLOVES, POWDER FREE | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| October 12, 2000 | K002745 | VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| October 11, 2000 | K002746 | VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| June 11, 1999 | K991686 | LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| September 5, 1997 | K971356 | POWDER FREE SYNTHETIC EXAMINATION GLOVES | LZA | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| June 27, 1997 | K970977 | LATEX EXAMINATION GLOVES, POWDER FREE | LYY | Substantially Equivalent | Arista Medi Prima | accessdata.fda.gov |
| February 10, 1997 | K964629 | VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Arista Medi Prima | accessdata.fda.gov |
| November 20, 1996 | K963742 | LATEX EXAMINATION GLOVES, POWDERED | LYY | Substantially Equivalent | Arista Medi Prima | accessdata.fda.gov |
| January 26, 1996 | K954153 | ARISTA VINYL EXAMINATION GLOVES | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| November 30, 1994 | K943707 | LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| June 23, 1994 | K934536 | VINYL EXAMINATION GLOVES (NON STERILE) | LYZ | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| August 5, 1993 | K921389 | POWDERFREE NATURAL LATEX GLOVES | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| December 20, 1989 | K896411 | REVISED PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | Pt. Trihasta Loka Persada | accessdata.fda.gov |
| December 1, 1989 | K896135 | STRAWBERRY SCENTED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
| April 26, 1989 | K891441 | NON-STERILE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Arista Latindo Industrial Ltd. P.T | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
Updated July 15, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.