Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Arista Latindo Industrial Ltd. P.T · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
213 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041745 | VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR | Arista Latindo Industrial Ltd. P.T | 2004-07-15 | 17 | 0 |
| K031944 | VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR | Arista Latindo Industrial Ltd. P.T | 2003-09-23 | 91 | 0 |
| K031913 | VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR | Arista Latindo Industrial Ltd. P.T | 2003-07-09 | 19 | 0 |
| K030245 | NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PUR | Arista Latindo Industrial Ltd. P.T | 2003-04-04 | 70 | 0 |
| K023753 | VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E | Arista Latindo Industrial Ltd. P.T | 2003-03-25 | 137 | 0 |
| K023754 | VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E | Arista Latindo Industrial Ltd. P.T | 2003-03-25 | 139 | 0 |
| K023072 | POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR | Arista Latindo Industrial Ltd. P.T | 2003-02-13 | 150 | 0 |
| K022987 | LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LES | Arista Latindo Industrial Ltd. P.T | 2002-10-21 | 42 | 0 |
| K021412 | LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED | Arista Latindo Industrial Ltd. P.T | 2002-06-07 | 35 | 0 |
| K013320 | BLUE LATEX EXAMINATION GLOVES, POWDER FREE | Arista Latindo Industrial Ltd. P.T | 2001-12-19 | 75 | 0 |
| K002745 | VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR | Arista Latindo Industrial Ltd. P.T | 2000-10-12 | 37 | 0 |
| K002746 | VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR | Arista Latindo Industrial Ltd. P.T | 2000-10-11 | 36 | 0 |
| K991686 | LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING | Arista Latindo Industrial Ltd. P.T | 1999-06-11 | 25 | 0 |
| K971356 | POWDER FREE SYNTHETIC EXAMINATION GLOVES | Arista Latindo Industrial Ltd. P.T | 1997-09-05 | 147 | 0 |
| K954153 | ARISTA VINYL EXAMINATION GLOVES | Arista Latindo Industrial Ltd. P.T | 1996-01-26 | 143 | 0 |
| K943707 | LATEX EXAMINATION GLOVES | Arista Latindo Industrial Ltd. P.T | 1994-11-30 | 121 | 0 |
| K934536 | VINYL EXAMINATION GLOVES (NON STERILE) | Arista Latindo Industrial Ltd. P.T | 1994-06-23 | 276 | 0 |
| K921389 | POWDERFREE NATURAL LATEX GLOVES | Arista Latindo Industrial Ltd. P.T | 1993-08-05 | 500 | 0 |
| K925683 | NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) | Arista Latindo Industrial Ltd. P.T | 1993-06-04 | 213 | 0 |
| K896135 | STRAWBERRY SCENTED LATEX EXAMINATION GLOVES | Arista Latindo Industrial Ltd. P.T | 1989-12-01 | 43 | 0 |
| K891441 | NON-STERILE LATEX EXAMINATION GLOVES | Arista Latindo Industrial Ltd. P.T | 1989-04-26 | 42 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda