510(k) Report

FDA applicant

Pt Mahakarya Inti Buana

Morawa, Sumut, ID9 decisions2005–20110 recalls

FDA records 9 decisions for Pt Mahakarya Inti Buana (Morawa, Sumut, ID) from 2005 to 2011: 9 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer 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 Mahakarya Inti Buana’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12009: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pt Mahakarya Inti Buana 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 Glove5decisions
  • LZAPolymer Patient Examination Glove4decisions

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K090464Black Nitrile Examination Gloves, Powder Free, Non SterilePt Mahakarya Inti Buana · 20092cite it

What has FDA decided for it lately?

  • K111300Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile (Green, Orange, Violet and White)Pt Mahakarya Inti Buana · 2011
  • K090464Black Nitrile Examination Gloves, Powder Free, Non SterilePt Mahakarya Inti Buana · 2009
  • K063581Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non SterilePt Mahakarya Inti Buana · 2007
  • K062313Senstouch High Risk Latex Examination Gloves, Powder Free, Non SterilePt Mahakarya Inti Buana · 2006
  • K061233Senstouch Powder Free Examination Gloves, Non SterilePt Mahakarya Inti Buana · 2006
  • K053305Senstouch Powdered Examination Gloves, Non SterilePt Mahakarya Inti Buana · 2006
  • K053366Nitrile Examination Gloves, Powdered, Non SterilePt Mahakarya Inti Buana · 2006
  • K053657Powder Free Nitrile Examination Gloves, Non-SterilePt Mahakarya Inti Buana · 2006

All 9 as Pt Mahakarya Inti Buana →