Arista Latindo Industrial Ltd. P.T: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Arista Latindo Industrial Ltd. P.T” (first 1989, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 9 | 9 |
| LYZ | Vinyl Patient Examination Glove | 8 | 8 |
| LZA | Polymer Patient Examination Glove | 4 | 4 |
Review panels
- General Hospital (21)
Most recent Arista Latindo Industrial Ltd. P.T 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041745 | VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR | LYZ | 2004-07-15 | 17 |
| K031944 | VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR | LZA | 2003-09-23 | 91 |
| K031913 | VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR | LYZ | 2003-07-09 | 19 |
| K030245 | NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR | LZA | 2003-04-04 | 70 |
| K023754 | VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E | LYZ | 2003-03-25 | 139 |
| K023753 | VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E | LYZ | 2003-03-25 | 137 |
| K023072 | POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR | LZA | 2003-02-13 | 150 |
| K022987 | LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | LYY | 2002-10-21 | 42 |
| K021412 | LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED | LYY | 2002-06-07 | 35 |
| K013320 | BLUE LATEX EXAMINATION GLOVES, POWDER FREE | LYY | 2001-12-19 | 75 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arista Latindo Industrial Ltd. P.T.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Arista Medi Prima (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arista Latindo Industrial Ltd. P.T?
FDA lists 21 510(k) clearances under the applicant name “Arista Latindo Industrial Ltd. P.T” (first 1989, latest 2004), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Arista Latindo Industrial Ltd. P.T?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arista Latindo Industrial Ltd. P.T is 75 days.
Which FDA product codes appear under Arista Latindo Industrial Ltd. P.T?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 9); LYZ (Vinyl Patient Examination Glove, 8); LZA (Polymer Patient Examination Glove, 4).
Next steps
- See all 21 Arista Latindo Industrial Ltd. P.T clearances with predicates and recalls
- Run predicate analysis for product code LYY, Arista Latindo Industrial Ltd. P.T's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.