510(k) Report

FDA applicant

Arista Medi Prima

Jakarta, ID3 decisions1996–19970 recalls

FDA records 3 decisions for Arista Medi Prima (Jakarta, ID) from 1996 to 1997: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). 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 Medi Prima’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arista Medi Prima since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arista Medi Prima by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove2decisions
  • LYZVinyl Patient Examination Glove1decision

What has FDA decided for it lately?

  • K970977Latex Examination Gloves, Powder FreeArista Medi Prima · 1997
  • K964629Vinyl Patient Examination GlovesArista Medi Prima · 1997
  • K963742Latex Examination Gloves, PowderedArista Medi Prima · 1996

All 3 as Arista Medi Prima →

Other applicant names beginning “Arista”

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

Arista Latindo Industrial Ltd. P.T 21