510(k) Report

FDA applicant

Pt. Mandiri Inti Buana

Medan, ID4 decisions2003–20050 recalls

FDA records 4 decisions for Pt. Mandiri Inti Buana (Medan, ID) from 2003 to 2005: 4 510(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. Mandiri Inti Buana’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pt. Mandiri Inti Buana since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pt. Mandiri Inti Buana by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pt. Mandiri Inti Buana’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

Which product codes does it file in?

  • LYYLatex Patient Examination Glove3decisions
  • LZAPolymer Patient Examination Glove1decision

What has FDA decided for it lately?

  • K051987Flexiskin Polymer Coated Latex Examination Gloves, Powder Free, Non-SterilePt. Mandiri Inti Buana · 2005
  • K042239Flexiskin Powder Free Nitrile Examination Gloves, Non SterilePt. Mandiri Inti Buana · 2004
  • K031754Flexiskin Powder Free Latex Examination Gloves, Non SterilePt. Mandiri Inti Buana · 2003
  • K031020Flexiskin Latex Examination Gloves, Powdered, Non SterilePt. Mandiri Inti Buana · 2003

All 4 as Pt. Mandiri Inti Buana →