510(k) Report

FDA applicant

P.T. Anlis Abadi Internasional

North Billerica, MA1 decision2005–20050 recalls

FDA records 1 decision for P.T. Anlis Abadi Internasional (North Billerica, MA) in 2005: 1 510(k) clearance. All are in product code LYY (Latex 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 P.T. Anlis Abadi Internasional’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for P.T. Anlis Abadi Internasional since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — P.T. Anlis Abadi Internasional 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 Glove1decision

What has FDA decided for it lately?

  • K051465Powdered Latex Patient Examination GlovesP.T. Anlis Abadi Internasional · 2005

The one decision as P.T. Anlis Abadi Internasional →