510(k) Report

FDA applicant

Pt Mbf Buana Multicorpora

Medan, ID2 decisions1995–19970 recalls

FDA records 2 decisions for Pt Mbf Buana Multicorpora (Medan, ID) from 1995 to 1997: 2 510(k) clearances. 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 Pt Mbf Buana Multicorpora’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pt Mbf Buana Multicorpora since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pt Mbf Buana Multicorpora 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

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K970115Powder Free Latex Examination GlovesPt Mbf Buana Multicorpora · 19971cites it

What has FDA decided for it lately?

  • K970115Powder Free Latex Examination GlovesPt Mbf Buana Multicorpora · 1997
  • K952197Glovetex (Multiple)Pt Mbf Buana Multicorpora · 1995

All 2 as Pt Mbf Buana Multicorpora →