FDA applicant

Arista Latindo Industrial Ltd. P.T

Jakarta Barat, ID21 decisions1989–20040 recalls

FDA records 21 decisions for Arista Latindo Industrial Ltd. P.T (Jakarta Barat, ID) from 1989 to 2004: 21 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Arista Latindo Industrial Ltd. P.T’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arista Latindo Industrial Ltd. P.T since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arista Latindo Industrial Ltd. P.T by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arista Latindo Industrial Ltd. P.T’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Arista”

FDA records each applicant name separately; these may or may not be the same firm.

Arista Medi Prima 3

Arista Latindo Industrial Ltd. P.T

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Arista”